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Evaluating long-term performance of Medtronic cardiac devices

Medtronic CRDM Product Performance Report

Medtronic · NCT00271180

This study is testing how well Medtronic heart devices, like pacemakers and defibrillators, work over the long term for people who have recently received or are about to receive one of these implants.

Quick facts

Study typeObservational
Enrollment20000 (estimated)
SexAll
SponsorMedtronic (industry)
Locations320 sites (Birmingham, Alabama and 319 other locations)
Trial IDNCT00271180 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term reliability and performance of Medtronic's marketed cardiac therapy products, including devices for pacing, sensing, and defibrillation. It involves analyzing the survival probabilities of various Medtronic cardiac rhythm products, such as implantable cardioverter defibrillators and pacemakers. Eligible participants include those who are indicated for implant or are within 30 days post-implant of a Medtronic device. The study will gather data from multiple locations to ensure a comprehensive evaluation of product performance.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who are indicated for the implantation of Medtronic cardiac devices or those who have recently undergone such an implantation.

Not a fit: Patients who are not receiving a Medtronic device or who are inaccessible for follow-up may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and reliability of cardiac devices, potentially improving patient outcomes.

How similar studies have performed: Other studies evaluating the performance of cardiac devices have shown success, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 319 other locations

+270 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia, Cardiac Pacing, Implantable Cardioverter Defibrillator, pacemaker, Sinus Bradycardia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.