NCT00271180 Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
| NCT ID | NCT00271180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic |
| Condition | Arrhythmia |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 1983-01 |
| Primary Completion | 2040-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 1983-01 with a primary completion date of 2040-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Medtronic CRM Clinical Trials
✉ medtroniccrmtrials@medtronic.comProduct Performance Report Study Leader
STUDY CHAIR
Medtronic
Frequently Asked Questions
Who can join the NCT00271180 clinical trial?
This trial is open to participants of all sexes, studying Arrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00271180 currently recruiting?
Yes, NCT00271180 is actively recruiting participants. Contact the research team at medtroniccrmtrials@medtronic.com for enrollment information.
Where is the NCT00271180 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Chandler, United States, Jonesboro, United States and 11 additional locations.
Who is sponsoring the NCT00271180 clinical trial?
NCT00271180 is sponsored by Medtronic. The principal investigator is Product Performance Report Study Leader at Medtronic. The trial plans to enroll 20,000 participants.