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

Recruiting · NCT00271180 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medtronic

View the official record on ClinicalTrials.gov →

Interventions studied

Device

What this trial is about

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.

Who can take part

Age range

No age limits stated

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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

Where it is running

60 locations listed across 37 US states.

Study site - Birmingham, Alabama, United States
Study site - Anchorage, Alaska, United States
Study site - Chandler, Arizona, United States
Study site - Jonesboro, Arkansas, United States
Study site - Little Rock, Arkansas, United States
Study site - Bakersfield, California, United States
Study site - Chula Vista, California, United States
Study site - La Jolla, California, United States
Study site - Los Angeles, California, United States
Study site - Palm Springs, California, United States
Study site - Rancho Mirage, California, United States
Study site - Redwood City, California, United States
Study site - Salinas, California, United States
Study site - San Diego, California, United States
Study site - Stanford, California, United States
Study site - Torrance, California, United States
Study site - Van Nuys, California, United States
Study site - Ventura, California, United States
Study site - Aurora, Colorado, United States
Study site - Centennial, Colorado, United States
Study site - Colorado Springs, Colorado, United States
Study site - Denver, Colorado, United States
Study site - Lakewood, Colorado, United States
Study site - Hartford, Connecticut, United States
Study site - New Haven, Connecticut, United States
Study site - Washington D.C., District of Columbia, United States
Study site - Bradenton, Florida, United States
Study site - Clearwater, Florida, United States
Study site - Hollywood, Florida, United States
Study site - Jacksonville, Florida, United States
Study site - Panama City, Florida, United States
Study site - Safety Harbor, Florida, United States
Study site - Sarasota, Florida, United States
Study site - Tampa, Florida, United States
Study site - Atlanta, Georgia, United States
Study site - Marietta, Georgia, United States
Study site - Evansville, Indiana, United States
Study site - Indianapolis, Indiana, United States
Study site - West Des Moines, Iowa, United States
Study site - Kansas City, Kansas, United States
Study site - Edgewood, Kentucky, United States
Study site - Louisville, Kentucky, United States
Study site - Baton Rouge, Louisiana, United States
Study site - Shreveport, Louisiana, United States
Study site - Baltimore, Maryland, United States
Study site - Bethesda, Maryland, United States
Study site - Clinton, Maryland, United States
Study site - Hyattsville, Maryland, United States
Study site - Salisbury, Maryland, United States
Study site - Silver Spring, Maryland, United States
Study site - Takoma Park, Maryland, United States
Study site - Boston, Massachusetts, United States
Study site - Lansing, Michigan, United States
Study site - Marquette, Michigan, United States
Study site - Ypsilanti, Michigan, United States
Study site - Coon Rapids, Minnesota, United States
Study site - Minneapolis, Minnesota, United States
Study site - Robbinsdale, Minnesota, United States
Study site - Rochester, Minnesota, United States
Study site - Saint Cloud, Minnesota, United States

Showing 60 of 333 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →