Overview

This trial is active, not recruiting.

Condition heart failure
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date June 2009
End date April 2017
Trial size 1778 participants
Trial identifier NCT00930904, 4196 Chronic Performance

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Lead-related complication rate
time frame: 5 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria - Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements - Patient has or is intended to receive an Attain Ability Model 4196 LV lead - Patient within 30 day post implant enrollment window Exclusion Criteria - Patient who is, or is expected to be inaccessible for follow-up - Patient with exclusion criteria required by local law - Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Additional Information

Official title Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study
Description Model 4196 LV lead complication-free survivability will be summarized.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.