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Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments for patients with Arrhythmia, Bradycardia, Heart Failure or Sinus Tachycardia

Research Study Title

Medtronic CRDM Product Performance Report

Purpose

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.

To Learn more
Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Lead Sponsor

Medtronic Cardiac Rhythm Disease Management

Duration

503 Months

Facility Type

N/A

Eligibility

Both Male and Female ages up to N/A

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

Site Locations (15)

Country State City Zip Facility and Contact
United States New Hampshire Lebanon Research Site
Austria Linz Research Site
Belgium Hasselt Research Site
Denmark Copenhagen Research Site
Denmark Kobenhavn Research Site
France Marseille Research Site
France Nantes Research Site
Germany Homburg/Saar Research Site
Italy Reggio Emilia Research Site
Italy Udine Research Site
Netherlands Eindhoven Research Site
Netherlands Rotterdam Research Site
Serbia Beograd Research Site
Sweden Skovde Research Site
Switzerland Zurich Research Site

Contact

Medtronic CRM Clinical Trials

E-mail:

NCT ID: NCT00271180

Date Last Changed: September 12, 2014

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