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

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.

Recruiting

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sinus Tachycardia Tachycardia Tachycardia, Sinus Tachycardia, Supraventricular

Sex eligibility

All sexes

Study type

Observational

Primary location

Chermside, Australia

About this study

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device

Primary outcomes

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).

All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.

Study contacts

Contact information is provided by the study sponsor or research team.

Medtronic CRM Clinical Trials

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Medtronic CRDM Product Performance Report

Acronym: PPR

Important dates

Study start: 1983
Primary completion: 2040
Study completion: 2040
First posted: Dec 30, 2005
Registry last updated: May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed