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