S-ICD System Clinical Investigatio

Completed

• Conditions: Ventricular tachyarrhythmias; 10007521

• Registration Number: NL-OMON36228
• Lead Sponsor: Cameron Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Patients with a Class I / Class II indication for ICD therapy according to the International guidelines for ICD therapy

Exclusion Criteria

Patients with symptomatic bradycardia
Patients with ventricular tachycardia which can be reliably terminated by antitachycardia pacing therapy
Patients with renal failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are afety and efficacy. Safety is defined a<br /><br>complication-free rate of 79% at 6 months follow-up.<br /><br>Efficacy will be assessed by measuring the conversion efficacy rate of<br /><br>ventricular fibrillation, which has to exceed 88%. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>