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\begin{document}

\title{Efficacy and safety of novel temperature-controlled radiofrequency
ablation system during pulmonary vein isolation in patients with
paroxysmal atrial fibrillation: TRAC-AF study}



\author[1]{Zdenek Starek}%
\author[1]{Frantisek Lehar}%
\author[2]{Petr Neuzil}%
\author[3]{Jan Petru}%
\author[4]{Josef Kautzner}%
\author[4]{Petr Peichl}%
\author[5]{Jean Albenque}%
\author[5]{Stéphane Combes}%
\author[6]{Srinivas Dukkipati}%
\author[7]{Vivek Reddy}%
\affil[1]{International Clinical Research Center}%
\affil[2]{Na Homolce Hospital}%
\affil[3]{Homolce Hospital}%
\affil[4]{IKEM}%
\affil[5]{Clinique Pasteur}%
\affil[6]{Icahn School of Medicine at Mount Sinai}%
\affil[7]{Mount Sinai School of Medicine}%


\vspace{-1em}



  
  \date{May 22, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Aims: Saline-irrigated radiofrequency ablation (RFA) for atrial
fibrillation (AF) is limited by the absence of reliable thermal feedback
limiting the utility of temperature monitoring for power titration. The
DiamondTemp (DT) ablation catheter allow efficient
temperature-controlled irrigated ablation. We sought to assess the
1-year clinical safety and efficacy of the DT catheter in treating
drug-refractory paroxysmal AF. Methods and results: The TRAC-AF trial
(NCT02821351) is a prospective, multi-center (n=4), single-arm study
that enrolled patients with symptomatic, drug-refractory paroxysmal AF.
Using the DT catheter, point-by-point ablation was performed around all
pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was
performed in a temperature-control mode (60oC, max 50 W) until the
split-tip EGM amplitude decreased by [?]75\%. The primary efficacy
endpoints included acute procedural success and freedom from AF at 12
months. A total of 62 patients (age 60.3 \selectlanguage{ngerman}± 11.4 years; 60\% male) were
evaluated after AF ablation using the DT catheter. The mean fluoroscopy
and RF ablation times were 9.4±6.4 min and 19.8±8.6 min, respectively.
Acute isolation of all PVs was achieved in 100\% of patients. There were
no steam pops and there were not seen any char or caugulum on the
catheter tip after ablation. There were very few serious
procedure/device-related adverse events including a single case of
cardiac tamponade (1.6\%). At 1 year, the freedom from AF was 74.2\%.
Conclusion: This first in man series demonstrates that
temperature-controlled irrigated RFA with the DT catheter is efficient,
safe, and effective in the treatment of paroxysmal AF.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{KEY WORDS}

Paroxysmal atrial fibrillation; pulmonary veins isolation; catheter
radiofrequency ablation; DiamondTemp ablation catheter;
temperature-controlled irrigated ablation; safety and efficacy

\textbf{INTRODUCTION}

Atrial fibrillation (AF) is the most common clinically significant
arrhythmia. It is a major public health concern affecting an estimated
2.3 million people in North America and 4.5 million people in Europe .
It has been projected that the prevalence of AF will increase 2.5 times
during the next 50 years in the United States . AF is associated with
increased cardiovascular morbidity and mortality and the prevalence
increases over time due to the aging population and increase in
age-specific occurrence of AF . Currently, catheter ablation for AF is a
widely recognized treatment in patients with drug refractory arrhythmia.
The predominant strategy is isolation of the pulmonary veins (PVI) by
circular radiofrequency lesions around their ostia in patients with both
paroxysmal and persistent AF supplemented by additional ablations, such
as linear lesions in the left atrium or ablation of fractionated atrial
potentials . The number of technological improvements is growing. For
example single shot ablation catheters, high resolution ablation
catheters, contact force-sensing technologies and improved navigation
technologies, which are aimed to improve outcomes of ablation
procedures. Despite technological innovations, currently point-by-point
radiofrequency (RF) ablation remains the most common technique to
achieve PVI. Despite significant improvements in catheter ablation
strategies to treat AF in recent years, recurrence rates of AF after RF
ablation due to electrical reconnections still remains relatively high,
ranging from 20-55\% . In the the GAP-AF study, 70\% of patients had PV
reconnections at 3 months post-ablation. This may be attributed to lack
of durable, contiguous, and transmural lesions . Although the point by
point method is principally simple, creating a transmural, continuous
lines around the PV ostia may be a major challenge. The major
improvement in the ablation technology in the last ten years is
technology of irrigated tip catheters. Saline irrigation of the tip of
the catheter decreased the incidence of thrombus and char formation on
the ablation tip and increase lesion size. However saline irrigation
limits the temperature feedback and those catheters are typically
operated in power control mode. Overall settings of irrigated catheters
can cause inadequate lesion creation during PVI.

DiamondTemp (DT) Cardiac Ablation System (DiamondTemp Catheter, EPIX
Therapeutics, Santa Clara, California, USA, formerly known as Advanced
Cardiac Therapeutics, which was acquired by Medtronic, Inc. (Dublin, IR)
in March 2019), is a recently developed ablation system based on
composite-tip, diamond-embedded, temperature sensing, saline-irrigated
RF ablation catheter with 6 insulated thermocouples on the ablation tip
surface which directly measure the tissue surface temperature. The DT
catheter allows ablation in temperature control mode with rapid
diffusion of heat due to an industrial diamond embeded catheter tip with
the potential to fastly create deeper and more transmural lesions.
According to animal data, 92.7\% of lesions during ablation of pig\selectlanguage{ngerman}´s
atria were transmural The aim of our work is to describe the first
multicenter clinical experience with the DT ablation system during
ablation of drug refractory, recurrent, symptomatic paroxysmal AF
(TRAC-AF study).

\textbf{METHODS}

The TRAC-AF (ACT DiamondTemp TempeRAture-Controlled and Contact Sensing
RF Ablation Clinical Trial for Atrial Fibrillation) trial is a
prospective, multi-center, open-label, single-arm study (NCT02821351)
that enrolled patients with symptomatic, drug-refractory paroxysmal AF
to undergo PVI using a novel catheter with a diamond embedded tip
(DiamondTemp Catheter, formerly Epix Therapeutics, Inc., Sunnyvale, CA,
now Medtronic, Inc. (Dublin, IR) in March 2019). The study was approved
by the institutional review boards at each of the 4 clinical sites. All
participants enrolled in this study provided informed consent. Of the 71
patients enrolled in this study, the acute procedure, 3-month PV
remapping, and 6 months outcome results were previously reported for 35
patients enrolled in one center (15).

Key inclusion criteria were: (i) age \selectlanguage{english}[?]18 years, (ii) recurrent and
symptomatic AF with \selectlanguage{english}[?]2 episodes in prior 12 months with at least one
episode documented by Holter monitoring, (iii) failure of at least one
class I-IV anti-arrhythmic drug (AAD), and (iv) able to provide informed
consent. Key exclusion criteria were: (i) prior left atrial ablation,
(ii) cardiac surgery within prior two months, (iii) intracardiac
thrombus on the day of the procedure by transesophageal
echocardiography, (iv) active infection, fever, or sepsis, (v)
uncontrolled NYHA class III or IV heart failure, (vi) unable or
unwilling to take anticoagulants, (vii) women of childbearing age who
are pregnant or not willing to use contraception for the duration of the
study, and (viii) life expectancy \textless{}1 year.

The details of the DiamondTemp (DT) catheter and system have previously
been reported (15). Briefly, the DT catheter is 7.5F and has a 4.1 mm
composite electrode tip that consists of a two-part platinum-iridium
electrode and two industrial grade diamonds that allow the rapid
dissipation of heat due to their high thermal diffusivity (Figure 1).
The distal aspect of the composite electrode is 0.6 mm and is
electrically insulated from the proximal component which allows for high
resolution EGM sensing. The rapid heat dissipation allows for a reduced
saline irrigation rate of 8 ml/min through 6 irrigation ports. Three
proximal and 3 distal thermocouples allow for accurate estimation of
tissue temperature. There are two additional proximal ring electrodes. A
custom RF generator (EPIX Therapeutics, Santa Clara, California, USA)
delivers RF energy in a temperature-control mode.

All ablation procedures were performed under conscious sedation.
Procedures were performed using a three-dimensional electroanatomical
mapping system (EnSite Velocity, Abbott, Plymouth, Minnesota, USA).
Standard double transseptal punctures were performed. The DT catheter
was placed within a deflectable sheath (Agilis, Abbott, Plymouth,
Minnesota, USA) and 20-pole circular mapping catheter was placed through
a second non-deflectable sheath (SL1, Abbot, Plymouth, Minnesota, USA).
PVI was performed with standard point-by-point method in a
temperature-control mode (limit temperature 60degC, maximum power 50W)
until a 75-80\% reduction in the split-tip EGM amplitude was achieved.
During ablation on the posterior wall of the left atrium, the target
temperature was reduced to 55degC. Saline irrigation rate was 2 ml/min
during mapping and 8 ml/min during ablation. Ipsilateral PVs were
isolated with a wide encircling lesion set (wide area circumferential
antral ablation (WACAA), see Figure 2. Additional ablations were
permitted in cases of atrial flutter or other concomitant arrhythmias
induced during the procedure.

Following ablation, all patients were discharged on oral anticoagulation
for at least 3 months. AADs were discontinued at the discretion of the
treating physician. Patients were followed with clinic visits at 3
months, 6 months, and 12 months post-procedure and Holter monitoring was
conducted at 3 months and 12 months following the procedure.

At 3 months after the index procedure, subgroup of patients from one
center underwent a repeat procedure to assess for PV reconnection,
regardless of the intervening symptomatology. During this procedure, the
durability of PVI was assessed with a circular mapping catheter. If PV
reconnection was identified, the DT catheter was used to ablate the
site(s) of electric reconnection to achieve re-isolation (15) Eight
reablated patients were excluded from evaluation and total number
evaluated patients in this work is 63.

Endpoints: The primary effectiveness endpoint was (i) acute procedural
success defined as electrical isolation of all clinically releveant PVs
with demonstration of block or isolation of signals confirmed after
ablation, (ii) freedom from AF during 12 months follow up. The primary
safety endpoint consisted of nature and frequency of serious adverse
events (SAE) and serious adverse device effects (SADE) during the
ablation procedure or within 7 days afterwards. Secondary safety outcome
consisted of nature and frequency of SAEs and SADEs up to 12 months
post-ablation. Adverse events (AEs) were adjudicated by a team of
investigators at the particular center.

Statistical analysis: Continuous variables were described as
mean+-standard deviation (SD), or median (minimum, maximum).

\textbf{RESULTS}

A total of 63 patients underwent PVI using the DT catheter and system.
The mean age of the patients was 60.3 +- 11.4 years; 60\% male (Table 1).
The mean CHA2DS2-VASc score of the subjects was 1,8 +- 1,2. A total of
77.1\% of patients were on oral anticoagulation, 6.3\% on ASA, and 9.5\%
did not take any medication at baseline, for details see Table 2.

The procedural characteristics are shown in Table 3. Mean fluoroscopy
and procedure times were 9.6 +- 6.6 min and 155 +- 47 min, respectively.
The mean number of RF applications per patient was 66.6 +- 24.0 with a
mean duration of 17.5 +- 2.4 sec per RF application. A total of 59 PVs
were targeted in the 63 patients. Seven patients (10\%) underwent
additional ablation in addition to PVI (four ablation of cavotricuspid
isthmus for typical atrial flutter, two ablation of atypical left atrial
flutter and one typical atrio-ventricular nodal tachycardia ablation).
The primary effectiveness endpoint of acute PVI was achieved in 100\% of
targeted PVs. The primary safety endpoint of SAEs or SADEs within 7 days
of the procedure occurred in two (2.9\%) patients. One patient developed
a delayed pericardial effusion 8 h after the procedure which was
successfully drained and the patient was discharged. A few weeks later,
the same patient returned with recurrent pericardial effusion that was
again drained. No further accumulation occurred, and the patient did
well in follow-up. The exact etiology of this effusion was unclear.
During the procedure, there were no instances of audible pops, and at
the end of the procedure, the intracardiac echocardiography catheter was
used to document the absence of any pericardial effusion. One patient
developed after the procedure, a transient ischemic attack (impairment
of vision) with complete resolution and no finding on CT of the brain.
Seven patients developed AEs, six pseudoaneurysm of femoral vein, one
patient had single orthostatic syncope day after procedure. During
follow-up, two patients suffered from back pain with complete
resolution, see Table 4. Two months following the ablation procedure, 1
patient died; a post-mortem examination indicated that the cause of
death was systolic heart failure related to coronary artery disease.
This was adjudicated to be unrelated to either the procedure or study
catheter.

As previously reported, subgroup of 23 patients from one center were
scheduled for a second PV remapping procedure at \textasciitilde{}3
months. Out of those, 8 patients underwent reisolation of PVs due to
reconnections (15). These eight reablated patients were excluded from
the evaluation of 12-month efficacy. In the surviving 62 patients
(without one deceased patient) the freedom from AF at 12 months was
74.2\%. Of the whole group of 62 patients 29 patients were totally
without antiarrhytmic therapy and 18 were remaining on class I or class
III AADs. A total of 25 patients used betablocker, for details see Table
2.

\textbf{DISCUSSION}

Point-by-point creation of the ablation lines using externally irrigated
ablation catheters in power control mode during PVI remain the standard
current procedure through its flexibility and ability to perform extra
PV ablation . However, there is still demand for improvement of
technologies to make procedure faster and lesions more durable.
Introduction of a new ablation system with the possibility of
temperature control mode should overcome limitations of standard
irrigated tip catheters, lead to deeper and more permanent lesions, and
reduce the incidence of the chronic reconnections. The DT Cardiac
Ablation System has several features for improved creation of the
ablation lesions. The diamond embedded tip of the catheter with very
rapid heat diffusion allows for creation of faster lesions and reduced
irrigation to 8ml/min. Reduced irrigation with a complex system of
surface thermocouples allows the use of temperature control mode with
better titration of energy during ablation with variable stability and
contact force and subsequently creates lesions more efficiently,
reliably, and safely. The composite, dual part tip of the DT catheter
enables sensing of high-resolution EGMs, which might be better for
monitoring of lesion creation and minimizing collateral injury. It is
expected, that ablation with a novel system will be faster and safer
with minimizing of pops or char formation.

The TRAC-AF study clearly shows, that despite short RF application time
in the majority of patients, durable PVI was achieved with a longterm
success rate comparable to patients ablated with standard irrigated tip
catheters . Our study confirmed the pilot results of Iwasawa et al with
a larger group of patients. We show that temperature-controlled,
saline-irrigated RF ablation with the DT Cardiac Ablation System
equipped with an array of thermocouples at the tip-tissue interface is
very efficient and safe with a high probability of achieving transmural
atrial lesions. Preclinical experimental data show that a 75\% reduction
in voltage was achieved with 13.3 +- 6.0 s of RF, and complete lesion
transmurality was achieved in 92.7\% of lesions .

A significantly lower total radiofrequency ablation time was seen with
the DT catheter compared to AF patients ablated with standard irrigation
catheters in other contemporary paroxysmal AF ablation studies, such as
the Fire and Ice Study (Cryoballoon or Radiofrequency Ablation for
Paroxysmal Atrial Fibrillation) and the Heartlight (CardioFocus,
Marlborough, Massachusetts) multicenter clinical trials , see Figure 3.

Total fluoroscopy time was significantly shorter in the DT group as well
(9.6 +- 6.6 min for TRACK AF patients, 16,6 +- 17,8 min. and 29.7 +- 21.0
min for Fire and Ice Study and Heartlight resp.), which is well-aligned
with the trend to decrease radiation exposure which has been
dramatically decreasing over the last decade for PVI. With older
technology we exploited our chances to decrease exposure through
operator experience, annual case volume, and technology evolution .
Contact force catheters are thought to be major contributor to the
trend, especially in more lengthy procedures for persistent AF .
Inclusion of other modalities in the ablation strategy, such as
pre-procedural computed tomography and 3D rotational angiography, has
also contributed to lower radiation exposure (11).

DT technology thus further allows to decrease exposure times for
patients and attending physicians, further decrease would be possible
only by fluorless procedures .

The 12-month rate of freedom from AF of 72.5\% is similar to the success
rates of catheter ablations with standard irrigated tip catheters , , .
This data support noninferiority of the new ablation system regarding
efficacy.

From a safety view, the DT catheter seems to be as safe as standard
contact force ablation catheters. There were no audible pops, or char
formation. There was only one delayed pericardial effusion related to
the ablation procedure. Rate of complications nonrelated or possibly
related to the investigational device was 4.3\% and was comparable with
complication rates during catheter ablation with standard irrigated tip
catheters

The presented study has several limitations. Our project is the first
larger study to deal with the new DT ablation system. The number of
patients is limited and the study has nonrandomized, single-arm design.
Comparison with other ablation studies is indirect and for a more
definitive confirmation of efficacy and safety, a randomized, large
study comparing this system with standard irrigated contact force
catheters is needed. Such a study which recruited patients with
paroxysmal AF has been recently completed and is to be published.

\textbf{Conclusions}

The TRAC AF study demonstrated that temperature-controlled, irrigated RF
ablation using DiamondTemp\selectlanguage{english} Cardiac Ablation System is efficient and
safe, and allows the rapid creation of durable lesions. Total ablation
time appears to be shorter in comparison with standard technology of
power-controlled, irrigated ablation using contact force sensor
catheters.

\textbf{Group Members}

Jiri Jez, MD \textsuperscript{1,2}

Martin Pesl, MD, PhD\textsuperscript{1,2,3}

Lucie Sediva, MD \textsuperscript{4}

Libor Dujka MD \textsuperscript{4}

Moritoshi Funasako MD \textsuperscript{4}

Bashar Aldhoon MD \textsuperscript{5}

Serge Boveda MD \textsuperscript{7,8}

\textbf{Figures}

Figure 1. DiamondTemp Catheter - the temperature-controlled RF ablation
catheter contains 6 thermocouples that are equally, radially spaced and
a diamond shunt network to facilitate the rapid conduction of thermal
energy.

Figure 2. 3D electroanatomical map of the left atrium with PVI lesion
set. Ipsilateral PV pairs were isolated with a single wide-area
circumferential antral ablation (WACAA) lesions. Red dots -- left PVs
WACAA, blue dots -- right PVs WACAA, yellow dots -- the place of
isolation of individual pair of PVs.

Figure 3 Graphical comparison of the total ablation time of the TRAC-AF
(ACT DiamondTemp Temperature-Controlled and Contact Sensing RF Ablation
Clinical Trial for Atrial Fibrillation) study and paroxysmal atrial
fibrillation studies using standard irrigated contact force catheters
(the TactiCath arm of the TOCCASTAR (TactiCath Contact Force Ablation
Catheter Study for Atrial Fibrillation), and the Thermocool arm of the
Heartlight clinical trial). PVI = pulmonary vein isolation; RF =
radiofrequency.

\textbf{TABLES}

Table 1 Baseline Clinical Characteristics (n=63)

Table 2 Drug management (n=63)

Table 3 Procedure Data (n=63)

Table 4 Safety Endpoints (n=63)

\textbf{References}

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\textbf{TABLES}

Table 1 Baseline Clinical Characteristics (n=63)\selectlanguage{english}
\begin{longtable}[]{@{}ll@{}}
\toprule
Table 1 Baseline Clinical Characteristics (n=63) & Table 1 Baseline
Clinical Characteristics (n=63)\tabularnewline
\midrule
\endhead
Age (yrs) & 60.3 \selectlanguage{ngerman}± 11.4\tabularnewline
Male & 38 (60.3)\tabularnewline
LVEF (\%) & 59.3 \selectlanguage{ngerman}± 7.5\tabularnewline
LA diameter (mm) & 4.4 \selectlanguage{ngerman}± 0.6\tabularnewline
Height (cm) & 173.8 \selectlanguage{ngerman}± 11.7\tabularnewline
Weight (kg) & 91.3 \selectlanguage{ngerman}± 17.5\tabularnewline
Resting Heart Rate (bpm) & 72.2 \selectlanguage{ngerman}± 17.6\tabularnewline
Resting Systolic Blood Pressure (mmHg) & 142.5 \selectlanguage{ngerman}± 17.6\tabularnewline
Resting Diastolic Blood Pressure (mmHg) & 82.6 \selectlanguage{ngerman}± 10.1\tabularnewline
Hemoglobin (g/l) & 140 \selectlanguage{ngerman}± 33.5\tabularnewline
Creatinine (\selectlanguage{greek}µ\selectlanguage{english}mol/l) & 88.5 \selectlanguage{ngerman}± 17.8\tabularnewline
Glomerular Filtration Rate (ml/min/1.73m\textsuperscript{2}) & 77.1 \selectlanguage{ngerman}±
19\tabularnewline
AF duration (months) & 40.5 \selectlanguage{ngerman}± 34.6\tabularnewline
Hypertension & 45 (71.4)\tabularnewline
Heart failure & 2 (3.2)\tabularnewline
Diabetes mellitus & 7 (11.1)\tabularnewline
Stroke & 5 (7.9)\tabularnewline
CAD & 6 (9.5)\tabularnewline
CHA2DS2-VASc & 1,8 \selectlanguage{ngerman}± 1,2\tabularnewline
Antiarrhythmic Therapy &\tabularnewline
Class I & 33 (52.4)\tabularnewline
Class II & 26 (41.3)\tabularnewline
Class III & 14 (22.2)\tabularnewline
Class IV & 0 (0)\tabularnewline
Anticoagulation/Antiagregation Therapy &\tabularnewline
Vitamin K Antagonist & 17 (27)\tabularnewline
Direct Oral Anticoagulants & 36 (57.1)\tabularnewline
Acetylsalicylic Acid & 4 (6.4)\tabularnewline
Values are mean \selectlanguage{ngerman}± SD or n (\%); AF = atrial fibrillation; CAD = coronary
artery disease; LA = left atrial; LVEF = left ventricular ejection
fraction. & Values are mean \selectlanguage{ngerman}± SD or n (\%); AF = atrial fibrillation;
CAD = coronary artery disease; LA = left atrial; LVEF = left ventricular
ejection fraction.\tabularnewline
\bottomrule
\end{longtable}\selectlanguage{ngerman}

Table 2 Drug management (n=63)\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
Table 2 Drug management (n=63*) & Table 2 Drug management (n=63*) &
Table 2 Drug management (n=63*) & Table 2 Drug management (n=63*) &
Table 2 Drug management (n=63*)\tabularnewline
\midrule
\endhead
& Baseline & 3 months & 6 months & 12 months\tabularnewline
& n=63 & n=63 & n=62 & n=62\tabularnewline
Antiarrhythmic Therapy & & & &\tabularnewline
Class I & 33 (52.4) & 29 (46) & 16 (25.8) & 13 (21)\tabularnewline
Class II & 26 (41.3) & 25 (39.7) & 25 (40.3) & 25 (40.3)\tabularnewline
Class III & 14 (22.2) & 13 (20.6) & 8 (12.9) & 5 (8.1)\tabularnewline
Class IV & 0 (0) & 0 (0) & 0 (0) & 0 (0)\tabularnewline
Without Therapy & 10 (15.9) & 13 (20.6) & 29 (46.8) & 29
(46.8)\tabularnewline
Anticoagulation/Antiagregation Therapy & & & &\tabularnewline
Vitamin K Antagonist & 17 (27) & 18 (28.6) & 16 (25.8) & 13
(21)\tabularnewline
Direct Oral Anticoagulants & 36 (57.1) & 37 (58.8) & 31 (50) & 22
(35.5)\tabularnewline
Acetylsalicylic Acid & 4 (6.3) & 4 (6.3) & 4 (6.5) & 4
(6.4)\tabularnewline
Without Therapy & 6 (9.5) & 4 (6.3) & 11 (17.7) & 23
(37.1)\tabularnewline
Missing event data from subject who died before 6M FU, values are n (\%)
& * Missing event data from subject who died before 6M FU, values are n
(\%) & * Missing event data from subject who died before 6M FU, values
are n (\%) & * Missing event data from subject who died before 6M FU,
values are n (\%) & * Missing event data from subject who died before 6M
FU, values are n (\%)\tabularnewline
\bottomrule
\end{longtable}

Table 3 Procedure Data (n=63)\selectlanguage{english}
\begin{longtable}[]{@{}ll@{}}
\toprule
Table 3 Procedure Data (n=63) & Table 3 Procedure Data
(n=63)\tabularnewline
\midrule
\endhead
No. of RF Applications Per Patient & 66.6 \selectlanguage{ngerman}± 24.0\tabularnewline
Ablation Duration (sec) & 17.5 \selectlanguage{ngerman}± 2.4\tabularnewline
Average Power (W) & 36.2 \selectlanguage{ngerman}± 2.7\tabularnewline
Max Power (W) & 50.8 \selectlanguage{ngerman}± 0.5\tabularnewline
Temperature Set-Point (°C) & 58.1 \selectlanguage{ngerman}± 1.6\tabularnewline
Max Temperature (°C) & 65.0 \selectlanguage{ngerman}± 3.5\tabularnewline
Average Temperature (°C) & 48.2 \selectlanguage{ngerman}± 1.9\tabularnewline
Max Impedance (\selectlanguage{english}) & 134.7 \selectlanguage{ngerman}± 31.2\tabularnewline
Average Impedance (\selectlanguage{english}) & 95.5 \selectlanguage{ngerman}± 8.9\tabularnewline
Total RF Ablation Time (min) & 19.8 \selectlanguage{ngerman}± 8.6\tabularnewline
Total Procedure Time (min) & 155 \selectlanguage{ngerman}± 47\tabularnewline
Total Fluoroscopy Time (mins) & 9.6 \selectlanguage{ngerman}± 6.6\tabularnewline
Total irrigated volume used for cooling (ml) & 322.6 \selectlanguage{ngerman}± 99\tabularnewline
Values are mean ± SD. & Values are mean \selectlanguage{ngerman}± SD.\tabularnewline
\bottomrule
\end{longtable}\selectlanguage{ngerman}

Table 4 Safety Endpoints (n=63)\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
Table 4 Safety Endpoints (n= 63) & Table 4 Safety Endpoints (n= 63) &
Table 4 Safety Endpoints (n= 63)\tabularnewline
\midrule
\endhead
& SAE & AE\tabularnewline
Primary Safety & 2 (2.9) & 4 (5.7)\tabularnewline
(Procedure through 7 d) & &\tabularnewline
Long Term Safety & 1 (1.4) & 0 (0)\tabularnewline
(7d through 30d) & &\tabularnewline
Chronic Safety (30d-12M) & 0 (0) & 2 (2.9)\tabularnewline
Values are n (\%) & Values are n (\%) & Values are n (\%)\tabularnewline
\bottomrule
\end{longtable}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Fig-1/Fig-1}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Fig-2/Fig-2}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Fig-3/Fig-3}

\end{center}
\end{figure}

\selectlanguage{english}
\FloatBarrier
\end{document}

