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)
Facility
City
Region
Status
—
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.
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.
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