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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT00271180
• Date of registration: 28/12/2005
• Prospective Registration: No
• Primary sponsor: Medtronic
• Public title: Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products PPR
• Scientific title: Medtronic CRDM Product Performance Report
• Date of first enrolment: January 1983
• Target sample size: 20000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT00271180
• Study type: Observational

Countries of recruitment

Australia, Austria, Belgium, Canada, China, Czechia, Denmark, Finland, Former Serbia and Montenegro, 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, United States

Contacts

• Name: Product Performance Report Study Leader
• Affiliation: Medtronic

• Name: Medtronic CRM Clinical Trials

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sinus Tachycardia

Heart Failure

Arrhythmia

Bradycardia

Intervention(s)

Device: Device

Primary Outcome(s)

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).]

Secondary ID(s)

602

Source(s) of Monetary Support

Please refer to primary and secondary sponsors