Recruiting

Observational Study

Sponsor:

Medtronic

Code:

NCT00271180

Conditions

Arrhythmia

Bradycardia

Heart Failure

Sinus Tachycardia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Device

Study Details

Brief summary:

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Conditions

Arrhythmia

Bradycardia

Heart Failure

Sinus Tachycardia

Study ID

NCT00271180

Start date

Jan, 1983

Status verified date

Aug, 2026

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria:

• Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB

AND one of the following must also apply:

  • Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
  • Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data

Exclusion Criteria:

  • Subjects who are, or will be inaccessible for follow-up
  • Subjects with exclusion criteria required by local law (EMEA only)
  • Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
  • Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Study Design

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Device

Primary outcome measure

  • Lead related complications for each lead model. [ Time Frame: Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive). ]

Central Contacts and Locations

Central contacts

Medtronic CRM Clinical Trials

medtroniccrmtrials@medtronic.com

Locations

Recruiting

Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Little Rock, Arkansas, United States

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La Jolla, California, United States

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Salinas, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Ventura, California, United States

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Aurora, Colorado, United States

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Centennial, Colorado, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Panama City, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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West Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Edgewood, Kentucky, United States

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Louisville, Kentucky, United States

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Bethesda, Maryland, United States

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Hyattsville, Maryland, United States

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Salisbury, Maryland, United States

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Takoma Park, Maryland, United States

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Boston, Massachusetts, United States

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Lansing, Michigan, United States

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Ypsilanti, Michigan, United States

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Coon Rapids, Minnesota, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Eatontown, New Jersey, United States

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Marlton, New Jersey, United States

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Morristown, New Jersey, United States

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Ocean City, New Jersey, United States

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Ridgewood, New Jersey, United States

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Albuquerque, New Mexico, United States

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Huntington, New York, United States

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New York, New York, United States

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Port Jefferson, New York, United States

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Poughkeepsie, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Columbia, South Carolina, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Tyler, Texas, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Falls Church, Virginia, United States

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Olympia, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Calgary, Canada

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Kingston, Canada

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Montreal, Canada

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Québec, Canada

More Information

Sponsor

Medtronic

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Cardiac Pacing
  • Implantable Cardioverter Defibrillator
  • pacemaker
  • Sinus Bradycardia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic on 2026-08-20.