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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source Medtronic
Contact Medtronic CRM Clinical Trials
Email medtroniccrmtrials@medtronic.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Device


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medtronic

Countries where clinical trial is conducted

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, 

Outcome

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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