The extravascular implantable cardioverter‐defibrillator: The pivotal study plan

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.

The development of the extravascular defibrillator with substernal lead placement: A new Frontier for device‐based treatment of sudden cardiac arrest

“…The complete body of preclinical and clinical evidence provided the confidence to enter a large-scale pivotal study. 43…”

“…Enrollment was completed in late 2021 with the study conclusion expected in April 2022. 43 Juergen Kuschyk http://orcid.org/0000-0001-7827-4974…”

“…The full set of EV ICD system design features and their operation is currently under evaluation within the pivotal study. 43…”

Leadless Cardiac Pacing: New Horizons

“…Furthermore, a case report of a Micra AV pacemaker implanted along with an S-ICD showed the feasibility of AV synchronous pacing alongside an extravascular ICD [ 48 ]; however, the lack of cross-communication between the two devices (made by different companies) highlights the complexity and the need for further clinical research. An alternative extravascular ICD (Medtronic) is currently being tested in a clinical study, the EV ICD study (NCT04060680); this device comprises a substernal, extravascular lead which, in addition to defibrillation, can enable epicardial ATP and pacing owing to the proximity to the heart [ 49 ].…”

Initial Experience with Intercostal Insertion of an Extravascular ICD Lead Compatible with Existing Pulse Generators

“…Placement of extravascular defibrillation electrodes in closer proximity to the heart requires less shock energy for defibrillation, and therefore smaller pulse generators, compared with the S-ICD. 21,22,23 To that end, substernal EV-ICD leads (Medtronic Inc, Minneapolis, MN) have been developed. Crozier et al 24 reported successful substernal implantation in 299 of 316 subjects (95%) with no procedural complications observed.…”