Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products (PPR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00271180 |
Recruitment Status :
Recruiting
First Posted : December 30, 2005
Last Update Posted : April 26, 2022
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Condition or disease | Intervention/treatment |
---|---|
Arrhythmia Bradycardia Heart Failure Sinus Tachycardia | Device: Device |
Study Type : | Observational |
Estimated Enrollment : | 20000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Medtronic CRDM Product Performance Report |
Study Start Date : | January 1983 |
Estimated Primary Completion Date : | December 2040 |
Estimated Study Completion Date : | December 2040 |
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271180
Contact: Medtronic CRM Clinical Trials | medtroniccrmtrials@medtronic.com |

Study Chair: | Product Performance Report Study Leader | Medtronic |
Responsible Party: | Medtronic |
ClinicalTrials.gov Identifier: | NCT00271180 |
Other Study ID Numbers: |
602 |
First Posted: | December 30, 2005 Key Record Dates |
Last Update Posted: | April 26, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Cardiac Pacing Implantable Cardioverter Defibrillator pacemaker Sinus Bradycardia |
Tachycardia Bradycardia Tachycardia, Sinus Heart Diseases Cardiovascular Diseases |
Arrhythmias, Cardiac Pathologic Processes Cardiac Conduction System Disease Tachycardia, Supraventricular |