Extravascular ICD Pivotal Study (EV ICD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tachycardia
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 393
- Locations
- 56
- Primary Endpoint
- Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Pivotal Summary:
The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
Continued Access Summary:
This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
Detailed Description
The study will enroll subjects who are indicated to receive an implantable defibrillator and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed until regulatory approval is received.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines \[i\], or ESC guidelines \[ii\].
- •Patient is at least 18 years of age and meets age requirements per local law.
- •Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
- •\[i\] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias. \[ii\] Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliot PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ. 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. European Heart Journal 2015 36:41 (2793-2867). https://doi.org/10.1093/eurheartj/ehv316
Exclusion Criteria
- •Patient is unwilling or unable to personally provide Informed Consent.
- •Patient has indications for bradycardia pacing \[iii\] or Cardiac Resynchronization Therapy (CRT) \[iv\] (Class I, IIa, or IIb indication).
- •Patient with an existing pacemaker, ICD, or CRT device implant or leads.
- •Patients with these medical interventions are excluded from participation in the study:
- •Prior sternotomy
- •Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis)
- •Prior abdominal surgery in the epigastric region
- •Planned sternotomy
- •Prior chest radiotherapy
- •Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
Outcomes
Primary Outcomes
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
Time Frame: At Implant
Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 6 such episodes may be induced to test device efficacy.
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 6 Months Post-implant
Time Frame: 6 Months (182 days) post implant
The primary safety endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 6 months (182 days) post-implant.