Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study

Medtronic0 sites1,847 target enrollmentJune 2009

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Medtronic
Enrollment: 1847
Primary Endpoint: Lead-related complication rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Detailed Description

Model 4196 LV lead complication-free survivability will be summarized.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

April 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Lead-related complication rate

Time Frame: 5 years

Secondary Outcomes

Percent of subjects with changes in electrode programming(5 Years)
Percent of fractures with loss of function(5 years)
Mean bipolar pacing threshold(1 year)
Types of lead-related events(5 years)
Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations(1 year)