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

RecruitingObservational study

Medtronic CRDM Product Performance Report

Who can join

All ages · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Medtronic · Participants: 20,000 · Started: 1983-01

Contact the study team

Official record on ClinicalTrials.gov — NCT00271180

Locations in the U.S.

AlabamaBirmingham
ArizonaChandler
ArkansasLittle Rock
CaliforniaLa Jolla
Salinas
Stanford
Torrance
Ventura
ColoradoAurora
Centennial
Colorado Springs
Lakewood
ConnecticutHartford
New Haven
District of ColumbiaWashington D.C.
FloridaClearwater
Hollywood
Jacksonville
Panama City
Safety Harbor
Sarasota
Tampa
GeorgiaAtlanta
IndianaEvansville
Indianapolis
IowaWest Des Moines
KansasKansas City
KentuckyEdgewood
Louisville
MarylandBethesda
Hyattsville
Salisbury
Takoma Park
MassachusettsBoston
MichiganLansing
Ypsilanti
MinnesotaCoon Rapids
Minneapolis
Robbinsdale
Rochester
Saint Cloud
MissouriColumbia
Kansas City
St Louis
NebraskaOmaha
New JerseyEatontown
Marlton
Morristown
Ocean City
Ridgewood
New MexicoAlbuquerque
New YorkHuntington
New York
Port Jefferson
Poughkeepsie
North CarolinaDurham
Raleigh
OhioCincinnati
Cleveland
Columbus
Toledo
OklahomaOklahoma City
PennsylvaniaAllentown
Bethlehem
Danville
Erie
Philadelphia
Pittsburgh
Wilkes-Barre
South CarolinaColumbia
TennesseeGermantown
Nashville
TexasAustin
Dallas
Fort Worth
Houston
Plano
Tyler
VermontBurlington
VirginiaCharlottesville
Falls Church
WashingtonOlympia
WisconsinMadison
Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.