MedPath

Attain StabilityTM Quad Clinical Study

Completed
Conditions
desynchronization
heart failure
10019280
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
NameTimeMethod
<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
NameTimeMethod
<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>
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