The extravascular implantable cardioverter-defibrillator: The pivotal study plan

Ian Crozier, David O'Donnell, Lucas Boersma, Francis Murgatroyd, Jaimie Manlucu, Bradley P Knight, Ulrika Maria Birgersdotter-Green, Christophe Leclercq, Amy Thompson, Robert Sawchuk, Sarah Willey, Christopher Wiggenhorn, Paul Friedman, Ian Crozier, David O'Donnell, Lucas Boersma, Francis Murgatroyd, Jaimie Manlucu, Bradley P Knight, Ulrika Maria Birgersdotter-Green, Christophe Leclercq, Amy Thompson, Robert Sawchuk, Sarah Willey, Christopher Wiggenhorn, Paul Friedman

Abstract

Background: Transvenous implantable cardioverter 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 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, multicenter, single-arm, nonrandomized, premarket 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 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.

Trial registration: ClinicalTrials.gov NCT04060680.

Keywords: ICD; anterior mediastinum; defibrillation; extravascular; subcutaneous; substernal.

Conflict of interest statement

Dr. Crozier is a consultant for and receives research support and fellow support from Medtronic plc and grants from Boston Scientific Corp. Dr. O'Donnell has received research support and/or served as consultant to Abbott and Medtronic. Prof. Boersma is a consultant for Medtronic, Boston Scientific, Philips, Acutus, and Adagio and his institution receives grant support from Medtronic and Boston Scientific. Dr. Murgatroyd is a consultant for Medtronic, Inc. In the last 3 years he has also consulted for Abbott, Inc, and Boston Scientific, Inc., and his department has received research support from Abbott, Inc, Boston Scientific, Inc. and Medtronic, Inc. Dr. Manlucu is a consultant for and receives research and fellowship support from Medtronic. She also has received research support from and/or served as consultant to Abbott, Boston Scientific and Baylis Medical. Dr. Knight is a consultant for and receives research support and fellowship support from Medtronic. He also has received research support from and/or served as consultant to Abbott, Boston Scientific, Biotronik, CVRx, Baylis, and Philips. Dr. Birgersdotter‐Green receives honoraria from Medtronic and BCS, receives honorarium and research grants from Abbott, and is on an advisory board for Biotronik. Prof. Leclercq receives speaker fees from Medtronic, Abbott, Biotronik, Boston, Microport and research grants from Biotronik, Medtronic. Ms. Thompson, Mr. Sawchuk, Ms. Willey, and Mr. Wiggenhorn are employees of Medtronic. Dr. Friedman has received research support and/or served as consultant to Abbott, Medtronic, Boston Scientific, and Leadex, with all proceeds going to Mayo Clinic. He has licensed intellectual property to NeoChord, Preventice, AliveCor, Anumana, Champion Medical, Marani Health, and MediCool.

© 2021 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.

Figures

Figure 1
Figure 1
EV ICD System. Extravascular implantable cardioverter defibrillator (EV ICD) and EV ICD quadripolar lead with passive fixation
Figure 2
Figure 2
EV ICD implant overview. Left panel: Lateral view. Tunneling rod tip at the top of the cardiac silhouette (1, Tunneling Rod, 2, Xiphisternal Junction, 3, Sternum, 4, Head). Right panel: Exterior view: tunneling rod tip at the top of the cardiac silhouette. EV, extravascular; ICD, implantable cardioverter defibrillator
Figure 3
Figure 3
EV ICD System in situ. Anteroposterior (left) and lateral (right) fluoroscopic images of fully implanted system (Image from EV ICD Pilot study patient). EV, extravascular; ICD, implantable cardioverter defibrillator
Figure 4
Figure 4
Study overview. AE, adverse event; PHD, pre‐hospital discharge

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Source: PubMed

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