Clinical Evaluation of the SonR atrial lead in the Paradym RF device
Completed
- Conditions
- heart failure10007521ventricular dysssynchrony
- Registration Number
- NL-OMON34489
- Lead Sponsor
- Sorin Group Nederland N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Indication for a biventricular defibrillator and chronic heart failure.
Exclusion Criteria
Contra-indication for standard pacing.
Contra-indication for ICD therapy.
Acute myocarditis.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Atrial lead complication rate superior to 90% after 3 months.<br /><br>Comparison of automatic and manual right ventricular stimulation threshold<br /><br>after 1 month.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Report Serious Adverse Events and Adverse Events.<br /><br>Report electrical functionality of the ICD.<br /><br>Report electrical functionality of the SonR atrial lead.<br /><br>Report hemodynamic performance measurements from the SonR atrial lead.</p><br>