Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT02294331
• Lead Sponsor: Medtronic

Brief Summary

Lead survivability will be summarized.

Detailed Description

The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV Leads. 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 Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lead complication	5 years	Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study.; Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.

Secondary Outcome Measures

Name	Time	Method
Lead survival estimate by model	5 years	An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model.
Types of lead-related adverse device effects	5 years	Summary statistics will be used to report types and rates of lead related adverse device effects (ADE). Examples of ADEs include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.
Returned lead analysis	5 years	A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.

Trial Locations

Locations (2)

Hattiesburg Clinic; 🇺🇸 Hattiesburg, Mississippi, United States

St Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States