Post market clinical follow-up study for the Pamira ICD lead family.
Withdrawn
- Conditions
- cardiac arrhythmias10007521
- Registration Number
- NL-OMON56034
- Lead Sponsor
- BIOTRONIK SE & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Standard indication for ICD therapy according to clinical guidelines.
Planned for de novo implantation of a BIOTRONIK ICD in combination with a
Pamira ICD lead.
Ability and willingness to use the CardioMessenger and acceptance of the
BIOTRONIK Home Monitoring® concept.
See CIP 8.3.1.
Exclusion Criteria
Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease.
Cardiac surgical post-implantation procedure planned within 12 months.
See CIP 8.3.2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to collect clinical data on the performance and safety<br /><br>of the Pamira lead by analyzing the Pamira related SADE-d events occurring<br /><br>during the implantation or in the 6 months thereafter.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective is to confirm the clinical safety by analyzing the<br /><br>Pamira-related SADE-d events occurring during the implantation or in the 3 and<br /><br>12 months thereafter, as well as the assessment of the appropriateness of right<br /><br>ventricular sensing and pacing at the 6- and 12-month FU.</p><br>