Attain StabilityTM Quad Clinical Study
Completed
- Conditions
- desynchronizationheart failure10019280
- Registration Number
- NL-OMON45275
- Lead Sponsor
- Medtronic BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy.
- Patient has signed and dated the study-specific Consent Form
Exclusion Criteria
- Patient has had a previous unsuccessful LV lead implant attempt.
- Patient has an existing epicardial LV lead
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Safety Objective: Lead complication-free rate at 6 months<br /><br>Primary Efficacy Objectives: Lead pacing capture thresholds at 6 months</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are descriptive in nature and are intended to provide<br /><br>additional information about the Attain Stability Quad Model 4798 LV lead.</p><br>