Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products (PPR)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Medtronic CRDM Product Performance Report|
- 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). ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 1983|
|Estimated Study Completion Date:||December 2024|
|Estimated Primary Completion Date:||December 2024 (Final data collection date for primary outcome measure)|
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271180
|Contact: Medtronic CRM Clinical Trialsfirstname.lastname@example.org|
|United States, New Hampshire|
|Lebanon, New Hampshire, United States|
|Reggio Emilia, Italy|
|Study Chair:||Product Performance Report Study Leader||Medtronic|