Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

Heart Failure Clinical Trial

— PPR  

Official title:

Medtronic CRDM Product Performance Report

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00271180
• Other study ID #: 602
• Status: Recruiting
• Start date: January 1983
• Est. completion date: December 2040

Study information

• Verified date: February 2024
• Source: Medtronic
• Contact: Medtronic CRM Clinical Trials
• Email: medtroniccrmtrials[@]medtronic.com
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Arrhythmia
• Bradycardia
• Heart Failure
• Sinus Tachycardia
• Tachycardia
• Tachycardia, Sinus

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).