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

Heart Failure Clinical Trial

Official title:

Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294331
• Other study ID #: Attain Performa™ PAS
• Status: Completed
• Start date: August 2014
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2022
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lead survivability will be summarized.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1900
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 Performa™ 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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	St Luke's University Health Network	Bethlehem	Pennsylvania
United States	Hattiesburg Clinic	Hattiesburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead complication	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.	5 years
Secondary	Types of lead-related adverse device effects	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.	5 years
Secondary	Returned lead analysis	A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.	5 years
Secondary	Lead survival estimate by model	An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model.	5 years