TY - JOUR
T1 - The extravascular implantable cardioverter-defibrillator
T2 - The pivotal study plan
AU - Crozier, Ian
AU - O'Donnell, David
AU - Boersma, Lucas
AU - Murgatroyd, Francis
AU - Manlucu, Jaimie
AU - Knight, Bradley P.
AU - Birgersdotter-Green, Ulrika Maria
AU - Leclercq, Christophe
AU - Thompson, Amy
AU - Sawchuk, Robert
AU - Willey, Sarah
AU - Wiggenhorn, Christopher
AU - Friedman, Paul
N1 - Publisher Copyright:
© 2021 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
KW - ICD
KW - anterior mediastinum
KW - defibrillation
KW - extravascular
KW - subcutaneous
KW - substernal
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U2 - 10.1111/jce.15190
DO - 10.1111/jce.15190
M3 - Article
C2 - 34322918
AN - SCOPUS:85111898354
SN - 1045-3873
VL - 32
SP - 2371
EP - 2378
JO - Journal of cardiovascular electrophysiology
JF - Journal of cardiovascular electrophysiology
IS - 9
ER -