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

Medtronic1,900 enrolled

Overview

Lead survivability will be summarized.

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 Type

OBSERVATIONAL

Enrollment

1,900

Conditions

Heart Failure

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (100)

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

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.

Time frame: 5 years

Returned lead analysis

A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.

Time frame: 5 years

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.

Time frame: 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Anchorage, Alaska, United States

Unnamed facility

Chandler, Arizona, United States

Unnamed facility

Gilbert, Arizona, United States

Unnamed facility

Jonesboro, Arkansas, United States

Unnamed facility

Bakersfield, California, United States

Unnamed facility

Rancho Mirage, California, United States

Unnamed facility

Redwood City, California, United States

Unnamed facility

Salinas, California, United States

Unnamed facility

San Diego, California, United States

...and 90 more locations