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Clinical Trials in South Korea / NCT00271180
Recruiting Observational

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

NCT00271180 · tracked via the Priya Life Science South Korea tracker
Sponsor
Medtronic
Phase
Observational
Started
1983-01
Last updated
2026-08-20

Condition(s) studied

ArrhythmiaBradycardiaHeart FailureSinus Tachycardia

Investigational drug(s) / intervention(s)

Device

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (333)

FacilityCityRegionStatus
— Birmingham Alabama Recruiting
— Anchorage Alaska Terminated
— Chandler Arizona Recruiting
— Jonesboro Arkansas Terminated
— Little Rock Arkansas Recruiting
— Bakersfield California Terminated
— Chula Vista California Completed
— La Jolla California Recruiting
— Los Angeles California Terminated
— Palm Springs California Terminated
— Rancho Mirage California Terminated
— Redwood City California Active Not Recruiting
— Salinas California Recruiting
— San Diego California Terminated
— Stanford California Recruiting
— Torrance California Recruiting
— Van Nuys California Terminated
— Ventura California Recruiting
— Aurora Colorado Recruiting
— Centennial Colorado Recruiting
— Colorado Springs Colorado Recruiting
— Denver Colorado Terminated
— Lakewood Colorado Recruiting
— Hartford Connecticut Recruiting
— New Haven Connecticut Recruiting
— Washington D.C. District of Columbia Recruiting
— Bradenton Florida Terminated
— Clearwater Florida Recruiting
— Hollywood Florida Recruiting
— Jacksonville Florida Recruiting
— Panama City Florida Recruiting
— Safety Harbor Florida Recruiting
— Sarasota Florida Recruiting
— Tampa Florida Recruiting
— Atlanta Georgia Recruiting
— Marietta Georgia Active Not Recruiting
— Evansville Indiana Recruiting
— Indianapolis Indiana Recruiting
— West Des Moines Iowa Recruiting
— Kansas City Kansas Recruiting

+ 293 more sites — see the full list on the official registry below.

More Medtronic trials in South Korea

Product Surveillance Registry Recruiting

Other trials for the same condition

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Recruiting
Personalized Health Coaching for Patients With HF Recruiting
Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study Recruiting
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00271180 on ClinicalTrials.gov ↗ ← All trials in South Korea