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Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

Medtronic CRDM Product Performance Report

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks how long Medtronic heart rhythm products already on the market keep working. It is for people who need or recently received one of these products, or who took part in a qualifying earlier study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal guardian must give written consent and/or permission to use your health information, as required by the study center. You must also meet one of the next two conditions.
  • You need an implant or received one within the past 30 days. It must be a Medtronic product already on the market that controls or tracks heartbeats, or gives shocks to correct heart rhythm.
  • You took part in a qualifying earlier study of a Medtronic product now on the market. Your implant and follow-up records must be complete, and you or your legal guardian must allow those records to be shared.

Who can't join

  • You cannot be reached for follow-up now or in the future.
  • Local law does not allow you to join. This rule applies only in Europe, the Middle East, and Africa.
  • You receive a Medtronic implant at a center not taking part in this study, and your implant details and current status cannot be confirmed within 30 days after the implant.
  • The study's enrollment limit for your specific Medtronic product has already been exceeded.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (113)

AK

AL

AR

AZ

CA

CO

CT

DC

FL

GA

IA

IN

KS

KY

LA

MA

MD

MI

MN

MO

MS

NC

NE

NJ

NM

NY

OH

OK

OR

PA

SC

TN

TX

VA

VT

WA

WI