Overview

This trial is active, not recruiting.

Condition heart failure
Sponsor Medtronic
Start date May 2011
End date February 2021
Trial size 367 participants
Trial identifier NCT01361685, 4396 Chronic Performance

Summary

Lead survivability will be summarized.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Model 4396 LV Lead-related complication rate
time frame: 5 years

Secondary Outcomes

Measure
Types of lead-related adverse device effects
time frame: 5 years
Percent of subjects with changes in electrode programming
time frame: 5 years
Number of fractures with and without loss of function
time frame: 5 years
Bipolar electrical performance at 1 year
time frame: 1 year
Bipolar pacing impedance
time frame: 1 year
Bipolar pacing capture threshold
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 4396 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® Family Left Ventricular Lead Chronic Performance Study
Description The purpose of this study is to evaluate long-term performance of the 4396 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 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic.