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The Extravascular Implantable Cardioverter-Defibrillator: The Pivotal Study Plan
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  • Ian Crozier,
  • David O'Donnell,
  • Lucas V.A. Boersma,
  • Francis Murgatroyd,
  • Jaimie Manlucu,
  • Bradley Knight,
  • Ulrika Birgersdotter-Green,
  • Christophe Leclercq,
  • Amy Thompson,
  • Robert Sawchuk,
  • Sarah Willey,
  • Christopher Wiggenhorn,
  • Paul Friedman
Ian Crozier
Christrchurch Hospital
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David O'Donnell
Austin and Repatriation Medical Center
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Lucas V.A. Boersma
St. Antonius Hospital
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Francis Murgatroyd
Kings College Hospital
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Jaimie Manlucu
London Health Sciences Centre
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Bradley Knight
Northwestern University Feinberg School of Medicine
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Ulrika Birgersdotter-Green
University of California San Diego
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Christophe Leclercq
University Hospital
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Amy Thompson
Medtronic plc
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Robert Sawchuk
Medtronic plc
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Sarah Willey
Medtronic plc
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Christopher Wiggenhorn
Medtronic, Inc
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Paul Friedman
Mayo Clinic
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Abstract

Background: Transvenous implantable cardiac defibrillators (TV ICD) provide life-saving therapy for millions of patients worldwide. However, they are susceptible to several potential short- and long- term complications including cardiac perforation and pneumothorax, lead dislodgement, venous obstruction, and infection. The extravascular ICD (EV ICD) system’s novel design and substernal implant approach avoids the risks associated with TV ICDs while still providing pacing features and similar generator size to TV ICDs. Study Design: The EV ICD pivotal study is a prospective, multi-center, single-arm, non-randomized, pre-market clinical study designed to examine the safety and acute efficacy of the system. This study will enroll up to 400 patients with a Class I or IIa indication for implantation of an ICD. Implanted subjects will be followed up to approximately 3.5 years, depending on when the patient is enrolled. Objective: The clinical trial is designed to demonstrate safety and effectiveness of the EV ICD system in human use. The safety endpoint is freedom from major complications, while the efficacy endpoint is defibrillation success. Both endpoints will be assessed against prespecified criteria. Additionally, this study will evaluate antitachycardia pacing (ATP) performance, electrical performance, extracardiac pacing sensation, asystole pacing, appropriate and inappropriate shocks, as well as a summary of adverse events. Conclusion: The EV ICD pivotal study is designed to provide clear evidence addressing the safety and efficacy performance of the EV ICD System.

Peer review status:ACCEPTED

15 Mar 2021Submitted to Journal of Cardiovascular Electrophysiology
17 Mar 2021Submission Checks Completed
17 Mar 2021Assigned to Editor
24 Mar 2021Reviewer(s) Assigned
12 Apr 2021Review(s) Completed, Editorial Evaluation Pending
03 May 2021Editorial Decision: Revise Minor
19 May 20211st Revision Received
24 May 2021Submission Checks Completed
24 May 2021Assigned to Editor
24 May 2021Reviewer(s) Assigned
08 Jun 2021Review(s) Completed, Editorial Evaluation Pending
08 Jun 2021Editorial Decision: Accept