Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT00869921
• Lead Sponsor: Medtronic

Brief Summary

Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

Detailed Description

Model 4195 LV lead complication-free survivability will be summarized.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1322

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lead-related complication rate.	Implant to 5 years post-implant.

Secondary Outcome Measures

Name	Time	Method
Types of Model 4195 lead-related events	5 years post implant