Heart Failure Clinical Trial
— PPROfficial title:
Medtronic CRDM Product Performance Report
NCT number | NCT00271180 |
Other study ID # | 602 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1983 |
Est. completion date | December 2040 |
Verified date | June 2024 |
Source | Medtronic |
Contact | Medtronic CRM Clinical Trials |
medtroniccrmtrials[@]medtronic.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | December 2040 |
Est. primary completion date | December 2040 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medtronic |
United States, Australia, Austria, Belgium, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lead related complications for each lead model. | 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. | 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). |
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