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Rationale and Design of the Lead EvaluAtion for Defibrillation and Reliability (LEADR) Study: Safety and Efficacy of a Novel ICD Lead Design
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  • George Crossley,
  • Prashanthan Sanders,
  • Paolo De Filippo,
  • Khaldoun Tarakji,
  • Bert Hansky,
  • Maully Shah,
  • Pamela Mason,
  • Baerbel Maus,
  • Keith Holloman
George Crossley
Vanderbilt University Medical Center

Corresponding Author:[email protected]

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Prashanthan Sanders
Royal Adelaide Hospital Libraries
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Paolo De Filippo
Aziende Socio Sanitarie Territoriale Papa Giovanni XXIII
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Khaldoun Tarakji
Cleveland Clinic
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Bert Hansky
Städtische Kliniken Bielefeld Germany
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Maully Shah
The Children’s Hospital Philadelphia PA USA
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Pamela Mason
University of Virginia Medical Center
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Baerbel Maus
Bakken Research Center Medtronic Inc Maastricht The Netherlands
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Keith Holloman
Medtronic Inc Mounds View Minnesota
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Background: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small diameter, lumenless, catheter delivered, defibrillator lead was developed with the aim to improve long term reliability. Methods and Results: The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients will participate for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled. Conclusion: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.
29 Dec 2021Submitted to Journal of Cardiovascular Electrophysiology
29 Dec 2021Submission Checks Completed
29 Dec 2021Assigned to Editor
29 Dec 2021Editorial Decision: Revise Minor
05 Jan 20221st Revision Received
05 Jan 2022Assigned to Editor
05 Jan 2022Submission Checks Completed
06 Jan 2022Reviewer(s) Assigned
03 Mar 2022Review(s) Completed, Editorial Evaluation Pending
04 Mar 2022Editorial Decision: Revise Minor
01 Aug 20222nd Revision Received
01 Aug 2022Submission Checks Completed
01 Aug 2022Assigned to Editor
02 Aug 2022Reviewer(s) Assigned
29 Aug 2022Review(s) Completed, Editorial Evaluation Pending
29 Aug 2022Editorial Decision: Revise Minor
04 Sep 20223rd Revision Received
06 Sep 2022Submission Checks Completed
06 Sep 2022Assigned to Editor
06 Sep 2022Reviewer(s) Assigned
07 Sep 2022Review(s) Completed, Editorial Evaluation Pending
12 Sep 2022Editorial Decision: Revise Minor
24 Sep 20224th Revision Received
26 Sep 2022Assigned to Editor
26 Sep 2022Submission Checks Completed
26 Sep 2022Reviewer(s) Assigned
26 Sep 2022Review(s) Completed, Editorial Evaluation Pending
27 Sep 2022Editorial Decision: Accept