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

Description

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.

Conditions

Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia

Study Overview

Study Details

Study overview

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.

Medtronic CRDM Product Performance Report

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

Condition
Arrhythmia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Birmingham, Alabama, United States,

Anchorage

Anchorage, Alaska, United States,

Chandler

Chandler, Arizona, United States,

Jonesboro

Jonesboro, Arkansas, United States,

Little Rock

Little Rock, Arkansas, United States,

Bakersfield

Bakersfield, California, United States,

Chula Vista

Chula Vista, California, United States,

Los Angeles

Los Angeles, California, United States,

Palm Springs

Palm Springs, California, United States,

Rancho Mirage

Rancho Mirage, California, United States,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic,

Product Performance Report Study Leader, STUDY_CHAIR, Medtronic

Study Record Dates

2040-12