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Completed

NCT Number: NCT02294331

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

Lead survivability will be summarized.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lead complication

    Time frame: 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 outcomes

  1. Types of lead-related adverse device effects

    Time frame: 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.

  2. Returned lead analysis

    Time frame: 5 years

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

  3. Lead survival estimate by model

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2014
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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