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

January 28, 2022 updated by: Medtronic

Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

Lead survivability will be summarized.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
  • Canada
      • Calgary, Canada
      • Ottawa, Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • London, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • La Rochelle, France
      • Nantes, France
  • Germany
      • Essen, Germany
      • Hannover, Germany
      • Ulm, Germany
  • Netherlands
      • Eindhoven, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
  • Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Liverpool, United Kingdom
      • Middlesbrough, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Chandler, Arizona, United States, 85226
      • Gilbert, Arizona, United States, 85295
    • Arkansas
      • Jonesboro, Arkansas, United States, 72410
    • California
      • Bakersfield, California, United States, 93301
      • Rancho Mirage, California, United States, 92270
      • Redwood City, California, United States, 94062
      • Salinas, California, United States, 93901
      • San Diego, California, United States, 92103
      • Stanford, California, United States, 94305
      • Torrance, California, United States, 90503
      • Van Nuys, California, United States, 91405
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Lakewood, Colorado, United States, 80228
    • Connecticut
      • New Haven, Connecticut, United States, 06519
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Bradenton, Florida, United States, 34205
      • Clearwater, Florida, United States, 33756
      • Jacksonville, Florida, United States, 32216
      • Safety Harbor, Florida, United States, 34695
    • Georgia
      • Albany, Georgia, United States, 31701
      • Marietta, Georgia, United States, 30060
    • Indiana
      • Evansville, Indiana, United States, 47710
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
      • Lexington, Kentucky, United States, 40503
      • Louisville, Kentucky, United States, 40207
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
    • Maryland
      • Hyattsville, Maryland, United States, 20782
      • Salisbury, Maryland, United States, 21804
      • Silver Spring, Maryland, United States, 20910
      • Takoma Park, Maryland, United States, 20912
    • Michigan
      • Lansing, Michigan, United States, 48912
      • Marquette, Michigan, United States, 49855
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
      • Robbinsdale, Minnesota, United States, 55422
      • Rochester, Minnesota, United States, 554905
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • Hattiesburg Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63110
    • Nevada
      • Las Vegas, Nevada, United States, 89169
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Huntington, New York, United States, 11743
      • New York, New York, United States, 10032
      • Poughkeepsie, New York, United States, 12601
      • Utica, New York, United States, 13501
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
      • Durham, North Carolina, United States, 27705
      • Raleigh, North Carolina, United States, 27610
    • Ohio
      • Akron, Ohio, United States, 44304
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Toledo, Ohio, United States, 43608
    • Oregon
      • Portland, Oregon, United States, 97220
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Bethlehem, Pennsylvania, United States
        • St Luke's University Health Network
      • Danville, Pennsylvania, United States, 17822
      • Erie, Pennsylvania, United States, 16550
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
      • Wilkes-Barre, Pennsylvania, United States, 18711
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75226
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Plano, Texas, United States, 75093
      • The Woodlands, Texas, United States, 77384
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Falls Church, Virginia, United States, 22042
      • Leesburg, Virginia, United States, 20176
    • Washington
      • Spokane, Washington, United States, 99204
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with an Attain Performa™ LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Attain Performa™ LV Leads
Patients who meet all Inclusion criteria and no Exclusion criteria and are implanted with an Attain Performa™ LV lead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Attain Performa™ PAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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