Evaluating long-term performance of Medtronic cardiac devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Birmingham, Alabama, United States Recruiting
• Chandler, Arizona, United States Recruiting
• Little Rock, Arkansas, United States Recruiting
• La Jolla, California, United States Recruiting
• Salinas, California, United States Recruiting
• Stanford, California, United States Recruiting

+288 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medtronic CRM Clinical Trials
• Email: medtroniccrmtrials@medtronic.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized pacemaker rate setting to improve symptoms in heart failure with bradycardia

  Researchers will try adjusting the pacemaker lower rate to a personalized, hemodynamically optimized heart rate to see if it reduces symptoms in people with heart failure who need a pacemaker.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07563153

• HeartBeam ECG Registry: See How Heartbeat Patterns Look Across People

  This registry tests HeartBeam ECG recordings in real-world patients to build a de-identified database for research.

  Recruiting HeartBeam, Inc. · Pittsburgh, Pennsylvania · NCT07501299

• RHYthm and Myocardial Function Relationship in Heart Disease

  This study tests how heart rhythm patterns relate to heart muscle function in adults with arrhythmias or cardiomyopathy.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07491237

• BIOTRONIK CSP Lead Registry for Left Bundle Branch Area Pacing

  This registry tests BIOTRONIK’s CSP-based pacing lead in patients needing a pacemaker or CRT, to see how it performs in real-life use.

  Recruiting at 12 sites Biotronik SE & Co. KG · Adelaide and 45 other locations · NCT07393009

• Left bundle branch area pacing with Tendril STS or UltiPace leads

  This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.

  Recruiting at 13 sites Abbott Medical Devices · Rio de Janeiro, Rio de Janeiro and 14 other locations · NCT07217392

• Cardiac rehabilitation cohort at Medicine Campus Davos to explore recovery

  This project will follow adults coming to Hochgebirgsklinik Davos for cardiac rehabilitation to see how their heart health and recovery progress over time.

  Recruiting Hochgebirgsklinik Davos · Davos, Kanton Graubünden · NCT07096973

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.