ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study

Recruiting

Conditions: heart rhythm disturbances
ventricular fibrillation
10007521

Registration Number: NL-OMON54505

Lead Sponsor: Medtronic BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Patient has a Class I or IIa indication for implantation of an ICD according to
the Guidelines.
Patient is at least 18 years of age.

Exclusion Criteria

Patient is unwilling or unable to personally provide Informed Consent.
Patient has indications for bradycardia pacing x or Cardiac Resynchronization
Therapy (CRT).
Patients with an existing pacemaker, ICD, or CRT device or leads.
Patients with medical interventions or specific medical conditions as specified
in CIP.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>See section 4 on protocol page 24<br /><br><br /><br>Primary Safety Objective: Demonstrate the freedom from major complications<br /><br>related to the EV ICD System and/or procedure at 6 months post-implant exceeds<br /><br>79% Objective Performance Criterion (OPC).<br /><br><br /><br><br /><br>Primary Efficacy Objective: Demonstrate the EV ICD defibrillation testing<br /><br>success rate at implant is greater than 88% OPC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See section 4 on protocol page 24<br /><br><br /><br>• Characterize appropriate and inappropriate shocks<br /><br>• Characterize electrical performance (pacing capture thresholds, pacing<br /><br>impedance, sensing amplitudes) over time<br /><br>• Characterize extracardiac pacing sensation<br /><br>• Characterize asystole pacing<br /><br>• Summarize ATP performance with spontaneous arrhythmias<br /><br>• Summarize adverse events<br /><br>• Characterize the EV ICD defibrillation testing success rate at 6 months<br /><br>post-implant.</p><br>