The extravascular implantable cardioverter-defibrillator: The pivotal study plan.
ICD
anterior mediastinum
defibrillation
extravascular
subcutaneous
substernal
Journal
Journal of cardiovascular electrophysiology
ISSN: 1540-8167
Titre abrégé: J Cardiovasc Electrophysiol
Pays: United States
ID NLM: 9010756
Informations de publication
Date de publication:
09 2021
09 2021
Historique:
revised:
23
05
2021
received:
15
03
2021
accepted:
08
06
2021
pubmed:
30
7
2021
medline:
21
10
2021
entrez:
29
7
2021
Statut:
ppublish
Résumé
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. 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. 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. The EV ICD pivotal study is designed to provide clear evidence addressing the safety and efficacy performance of the EV ICD System.
Sections du résumé
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.
Identifiants
pubmed: 34322918
doi: 10.1111/jce.15190
pmc: PMC9290824
doi:
Banques de données
ClinicalTrials.gov
['NCT04060680']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2371-2378Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2021 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.
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