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

Recruiting

• Conditions: Bradycardia; Heart Failure; Arrhythmia; Sinus Tachycardia

• Registration Number: NCT00271180
• Lead Sponsor: Medtronic

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.

Detailed Description

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

Study Timeline

• Study Start: 1983-01
• Study First Submitted: 2005-12-28
• Study First Submitted QC: 2005-12-28
• Study First Posted: 2005-12-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2025-03-25
• Primary Completion: 2040-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lead related complications for each lead model.	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.