AzTrials
AzTrials

ArrhythmiaPPRNCT00271180

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

An observational study of Arrhythmia and Bradycardia, run by Medtronic at 333 sites in 35 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Arrhythmia, Bradycardia, Heart Failure
What is being tested?
Device
Type of treatment
Medical device
How many people
20,000 participants
Where
333 sitesin 35 countries
Study dates
Jan 1983to Dec 2040
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Subjects implanted with Medtronic qualifying cardiac rhythm product.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

333 sites in 35 countries. Contact the study team or a site near you to ask about taking part.

Medtronic CRM Clinical Trials contact

medtroniccrmtrials@medtronic.com

333 sites in 35 countries

United States113 sites, 84 recruiting

  • Study site

    Akron, Ohio

    Terminated

  • Study site

    Albuquerque, New Mexico

    Recruiting

  • Study site

    Allentown, Pennsylvania

    Recruiting

  • Study site

    Anchorage, Alaska

    Terminated

  • Study site

    Atlanta, Georgia

    Recruiting

  • Study site

    Aurora, Colorado

    Recruiting

  • Study site

    Austin, Texas

    Recruiting

  • Study site

    Bakersfield, California

    Terminated

  • Study site

    Baltimore, Maryland

    Terminated

  • Study site

    Baton Rouge, Louisiana

    Terminated

  • Study site

    Bethesda, Maryland

    Recruiting

  • Study site

    Bethlehem, Pennsylvania

    Recruiting

  • Study site

    Birmingham, Alabama

    Recruiting

  • Study site

    Boston, Massachusetts

    Recruiting

  • Study site

    Bradenton, Florida

    Terminated

  • Study site

    Burlington, Vermont

    Recruiting

  • Study site

    Centennial, Colorado

    Recruiting

  • Study site

    Chandler, Arizona

    Recruiting

  • Study site

    Charlottesville, Virginia

    Recruiting

  • Study site

    Chula Vista, California

    Completed

  • Study site

    Cincinnati, Ohio

    Recruiting

  • Study site

    Clearwater, Florida

    Recruiting

  • Study site

    Cleveland, Ohio

    Recruiting

  • Study site

    Clinton, Maryland

    Terminated

  • Study site

    Colorado Springs, Colorado

    Recruiting

  • Study site

    Columbia, Missouri

    Recruiting

  • Study site

    Columbia, South Carolina

    Recruiting

  • Study site

    Columbus, Ohio

    Recruiting

  • Study site

    Coon Rapids, Minnesota

    Recruiting

  • Study site

    Dallas, Texas

    Recruiting

  • Study site

    Danville, Pennsylvania

    Recruiting

  • Study site

    Denver, Colorado

    Terminated

  • Study site

    Durham, North Carolina

    Recruiting

  • Study site

    Eatontown, New Jersey

    Recruiting

  • Study site

    Edgewood, Kentucky

    Recruiting

  • Study site

    Erie, Pennsylvania

    Recruiting

  • Study site

    Evansville, Indiana

    Recruiting

  • Study site

    Falls Church, Virginia

    Recruiting

  • Study site

    Fort Worth, Texas

    Recruiting

  • Study site

    Germantown, Tennessee

    Recruiting

  • Study site

    Hartford, Connecticut

    Recruiting

  • Study site

    Hattiesburg, Mississippi

    Terminated

  • Study site

    Hollywood, Florida

    Recruiting

  • Study site

    Houston, Texas

    Recruiting

  • Study site

    Huntington, New York

    Recruiting

  • Study site

    Hyattsville, Maryland

    Recruiting

  • Study site

    Indianapolis, Indiana

    Recruiting

  • Study site

    Jacksonville, Florida

    Recruiting

  • Study site

    Jonesboro, Arkansas

    Terminated

  • Study site

    Kansas City, Kansas

    Recruiting

  • Study site

    Kansas City, Missouri

    Recruiting

  • Study site

    La Jolla, California

    Recruiting

  • Study site

    Lakewood, Colorado

    Recruiting

  • Study site

    Lancaster, Pennsylvania

    Terminated

  • Study site

    Lansing, Michigan

    Recruiting

  • Study site

    Little Rock, Arkansas

    Recruiting

  • Study site

    Los Angeles, California

    Terminated

  • Study site

    Louisville, Kentucky

    Recruiting

  • Study site

    Madison, Wisconsin

    Recruiting

  • Study site

    Manhasset, New York

    Active, not recruiting

  • Study site

    Marietta, Georgia

    Active, not recruiting

  • Study site

    Marlton, New Jersey

    Recruiting

  • Study site

    Marquette, Michigan

    Terminated

  • Study site

    Milwaukee, Wisconsin

    Recruiting

  • Study site

    Minneapolis, Minnesota

    Recruiting

  • Study site

    Morristown, New Jersey

    Recruiting

  • Study site

    Nashville, Tennessee

    Recruiting

  • Study site

    New Brunswick, New Jersey

    Terminated

  • Study site

    New Haven, Connecticut

    Recruiting

  • Study site

    New York, New York

    Recruiting

  • Study site

    Ocean City, New Jersey

    Recruiting

  • Study site

    Oklahoma City, Oklahoma

    Recruiting

  • Study site

    Olympia, Washington

    Recruiting

  • Study site

    Omaha, Nebraska

    Recruiting

  • Study site

    Palm Springs, California

    Terminated

  • Study site

    Panama City, Florida

    Recruiting

  • Study site

    Philadelphia, Pennsylvania

    Recruiting

  • Study site

    Pittsburgh, Pennsylvania

    Recruiting

  • Study site

    Plano, Texas

    Recruiting

  • Study site

    Port Jefferson, New York

    Recruiting

  • Study site

    Portland, Oregon

    Terminated

  • Study site

    Poughkeepsie, New York

    Recruiting

  • Study site

    Raleigh, North Carolina

    Recruiting

  • Study site

    Rancho Mirage, California

    Terminated

  • Study site

    Redwood City, California

    Active, not recruiting

  • Study site

    Ridgewood, New Jersey

    Recruiting

  • Study site

    Robbinsdale, Minnesota

    Recruiting

  • Study site

    Rochester, Minnesota

    Recruiting

  • Study site

    Safety Harbor, Florida

    Recruiting

  • Study site

    Saint Cloud, Minnesota

    Recruiting

  • Study site

    Saint Paul, Minnesota

    Terminated

  • Study site

    Salinas, California

    Recruiting

  • Study site

    Salisbury, Maryland

    Recruiting

  • Study site

    San Diego, California

    Terminated

  • Study site

    Sarasota, Florida

    Recruiting

  • Study site

    Shreveport, Louisiana

    Terminated

  • Study site

    Silver Spring, Maryland

    Terminated

  • Study site

    Spokane, Washington

    Active, not recruiting

  • Study site

    St Louis, Missouri

    Recruiting

  • Study site

    Stanford, California

    Recruiting

  • Study site

    Takoma Park, Maryland

    Recruiting

  • Study site

    Tampa, Florida

    Recruiting

  • Study site

    The Woodlands, Texas

    Terminated

  • Study site

    Toledo, Ohio

    Recruiting

  • Study site

    Torrance, California

    Recruiting

  • Study site

    Tyler, Texas

    Recruiting

  • Study site

    Utica, New York

    Terminated

  • Study site

    Van Nuys, California

    Terminated

  • Study site

    Ventura, California

    Recruiting

  • Study site

    Washington D.C., District of Columbia

    Recruiting

  • Study site

    West Des Moines, Iowa

    Recruiting

  • Study site

    Wilkes-Barre, Pennsylvania

    Recruiting

  • Study site

    Ypsilanti, Michigan

    Recruiting

Other trials in United States

Japan28 sites, 24 recruiting

  • Study site

    Ageo

    Recruiting

  • Study site

    Bunkyō City

    Recruiting

  • Study site

    Gifu

    Recruiting

  • Study site

    Hidaka

    Recruiting

  • Study site

    Hiroshima

    Recruiting

  • Study site

    Kagoshima

    Recruiting

  • Study site

    Kamakura

    Recruiting

  • Study site

    Kawasaki

    Recruiting

  • Study site

    Kitakyushu

    Recruiting

  • Study site

    Koshigaya

    Recruiting

  • Study site

    Kumamoto

    Recruiting

  • Study site

    Kyoto

    Recruiting

  • Study site

    Minatoku

    Completed

  • Study site

    Mitaka

    Recruiting

  • Study site

    Nagoya

    Recruiting

  • Study site

    Niigata

    Recruiting

  • Study site

    Okayama

    Recruiting

  • Study site

    Ōsaka-sayama

    Terminated

  • Study site

    Sapporo

    Recruiting

  • Study site

    Shinagawa-Ku

    Recruiting

  • Study site

    Shizuoka

    Recruiting

  • Study site

    Suita

    Recruiting

  • Study site

    Tokyo

    Terminated

  • Study site

    Toyoake

    Recruiting

  • Study site

    Tsukuba

    Recruiting

  • Study site

    Urasoe

    Recruiting

  • Study site

    Yamagata

    Terminated

  • Study site

    Yokohama

    Recruiting

Other trials in Japan

France23 sites, 12 recruiting

  • Study site

    Avignon

    Recruiting

  • Study site

    Bayonne

    Terminated

  • Study site

    Brest

    Recruiting

  • Study site

    Caen

    Recruiting

  • Study site

    Chambray-lès-Tours

    Active, not recruiting

  • Study site

    Clermont-Ferrand

    Recruiting

  • Study site

    Dijon

    Recruiting

  • Study site

    La Rochelle

    Recruiting

  • Study site

    La Tronche

    Active, not recruiting

  • Study site

    Lille

    Active, not recruiting

  • Study site

    Montpellier

    Recruiting

  • Study site

    Nantes

    Recruiting

  • Study site

    Neuilly-sur-Seine

    Terminated

  • Study site

    Paris

    Recruiting

  • Study site

    Pessac

    Active, not recruiting

  • Study site

    Pringy

    Recruiting

  • Study site

    Rennes

    Active, not recruiting

  • Study site

    Rouen

    Recruiting

  • Study site

    Saint-Priest-en-Jarez

    Active, not recruiting

  • Study site

    Strasbourg

    Terminated

  • Study site

    Toulouse

    Recruiting

  • Study site

    Vandœuvre-lès-Nancy

    Active, not recruiting

  • Study site

    Villeurbanne

    Active, not recruiting

Other trials in France

Germany18 sites, 9 recruiting

  • Study site

    Aachen

    Recruiting

  • Study site

    Bad Oeynhausen

    Recruiting

  • Study site

    Bielefeld

    Recruiting

  • Study site

    Bremen

    Recruiting

  • Study site

    Cologne

    Recruiting

  • Study site

    Dresden

    Terminated

  • Study site

    Düsseldorf

    Recruiting

  • Study site

    Essen

    Terminated

  • Study site

    Hamburg

    Terminated

  • Study site

    Hanover

    Recruiting

  • Study site

    Heidelberg

    Terminated

  • Study site

    Homburg

    Terminated

  • Study site

    Jena

    Completed

  • Study site

    München

    Recruiting

  • Study site

    Münster

    Completed

  • Study site

    Tübingen

    Terminated

  • Study site

    Ulm

    Recruiting

  • Study site

    Villingen-Schwenningen

    Terminated

Other trials in Germany

China17 sites, 12 recruiting

  • Study site

    Beijing

    Recruiting

  • Study site

    Changsha

    Terminated

  • Study site

    Dalian

    Recruiting

  • Study site

    Fuzhou

    Terminated

  • Study site

    Guangzhou

    Recruiting

  • Study site

    Hangzhou

    Recruiting

  • Study site

    Harbin

    Recruiting

  • Study site

    Kunming

    Recruiting

  • Study site

    Nanchang

    Recruiting

  • Study site

    Nanjing

    Recruiting

  • Study site

    Shanghai

    Recruiting

  • Study site

    Shantou

    Terminated

  • Study site

    Suining

    Recruiting

  • Study site

    Suzhou

    Recruiting

  • Study site

    Taiyuan

    Terminated

  • Study site

    Tianjin

    Terminated

  • Study site

    Ürümqi

    Recruiting

Other trials in China

Spain14 sites, 12 recruiting

  • Study site

    A Coruña

    Recruiting

  • Study site

    Barcelona

    Active, not recruiting

  • Study site

    Córdoba

    Recruiting

  • Study site

    Girona

    Recruiting

  • Study site

    Granada

    Recruiting

  • Study site

    Madrid

    Recruiting

  • Study site

    Palma de Mallorca

    Recruiting

  • Study site

    Salamanca

    Recruiting

  • Study site

    Santa Cruz de Tenerife

    Recruiting

  • Study site

    Santiago de Compostela

    Recruiting

  • Study site

    Toledo

    Recruiting

  • Study site

    Valencia

    Recruiting

  • Study site

    Valladolid

    Recruiting

  • Study site

    Vitoria-Gasteiz

    Active, not recruiting

Other trials in Spain

United Kingdom13 sites, 10 recruiting

  • Study site

    Birmingham

    Recruiting

  • Study site

    Blackpool

    Terminated

  • Study site

    Bristol

    Recruiting

  • Study site

    Leeds

    Recruiting

  • Study site

    Leicester

    Recruiting

  • Study site

    Liverpool

    Recruiting

  • Study site

    London

    Recruiting

  • Study site

    Manchester

    Recruiting

  • Study site

    Middlesbrough

    Recruiting

  • Study site

    Northampton

    Terminated

  • Study site

    Nottingham

    Terminated

  • Study site

    Sheffield

    Recruiting

  • Study site

    Southampton

    Recruiting

Other trials in United Kingdom

Italy12 sites, 8 recruiting

  • Study site

    Ancona

    Terminated

  • Study site

    Bari

    Recruiting

  • Study site

    Bologna

    Recruiting

  • Study site

    Brescia

    Active, not recruiting

  • Study site

    Castrovillari

    Recruiting

  • Study site

    Cotignola

    Completed

  • Study site

    Lecce

    Recruiting

  • Study site

    Milan

    Recruiting

  • Study site

    Monza

    Recruiting

  • Study site

    Pisa

    Completed

  • Study site

    Taranto

    Recruiting

  • Study site

    Udine

    Recruiting

Other trials in Italy

South Korea11 sites, 2 recruiting

  • Study site

    Busan

    Completed

  • Study site

    Cheongju-si

    Completed

  • Study site

    Daegu

    Completed

  • Study site

    Daejeon

    Completed

  • Study site

    Gwangju

    Completed

  • Study site

    Gyeonggi-do

    Recruiting

  • Study site

    Jeonju

    Completed

  • Study site

    Seongnam-si

    Completed

  • Study site

    Seoul

    Recruiting

  • Study site

    Suwon

    Completed

  • Study site

    Yangsan

    Completed

Other trials in South Korea

Netherlands10 sites, 3 recruiting

  • Study site

    Amsterdam

    Active, not recruiting

  • Study site

    Breda

    Terminated

  • Study site

    Eindhoven

    Active, not recruiting

  • Study site

    Enschede

    Active, not recruiting

  • Study site

    Groningen

    Active, not recruiting

  • Study site

    Leiden

    Active, not recruiting

  • Study site

    Maastricht

    Recruiting

  • Study site

    Nieuwegein

    Recruiting

  • Study site

    Rotterdam

    Recruiting

  • Study site

    The Hague

    Active, not recruiting

Other trials in Netherlands

India7 sites, 7 recruiting

  • Study site

    Bangalore

    Recruiting

  • Study site

    Chennai

    Recruiting

  • Study site

    Gūrgaon

    Recruiting

  • Study site

    Hyderabad

    Recruiting

  • Study site

    Jaipur

    Recruiting

  • Study site

    Kochi

    Recruiting

  • Study site

    New Delhi

    Recruiting

Other trials in India

Switzerland7 sites, 4 recruiting

  • Study site

    Basel

    Recruiting

  • Study site

    Bern

    Recruiting

  • Study site

    Fribourg

    Active, not recruiting

  • Study site

    Geneva

    Recruiting

  • Study site

    Lausanne

    Active, not recruiting

  • Study site

    Lugano

    Active, not recruiting

  • Study site

    Zurich

    Recruiting

Other trials in Switzerland

Belgium6 sites, 4 recruiting

  • Study site

    Bruges

    Recruiting

  • Study site

    Brussels

    Recruiting

  • Study site

    Edegem

    Active, not recruiting

  • Study site

    Leuven

    Recruiting

  • Study site

    Liège

    Recruiting

  • Study site

    Yvoir

    Terminated

Other trials in Belgium

Denmark5 sites, 2 recruiting

  • Study site

    Aarhus

    Terminated

  • Study site

    Copenhagen

    Recruiting

  • Study site

    Hellerup

    Active, not recruiting

  • Study site

    Hillerød

    Terminated

  • Study site

    Odense

    Recruiting

Other trials in Denmark

Portugal5 sites, 4 recruiting

  • Study site

    Carnaxide

    Recruiting

  • Study site

    Creixomil

    Recruiting

  • Study site

    Lisbon

    Active, not recruiting

  • Study site

    Porto

    Recruiting

  • Study site

    Santarém

    Recruiting

Other trials in Portugal

Australia4 sites

  • Study site

    Chermside

    Terminated

  • Study site

    Douglas

    Terminated

  • Study site

    Murdoch

    Terminated

  • Study site

    Southport

    Terminated

Other trials in Australia

Austria4 sites, 4 recruiting

  • Study site

    Graz

    Recruiting

  • Study site

    Innsbruck

    Recruiting

  • Study site

    Linz

    Recruiting

  • Study site

    Vienna

    Recruiting

Other trials in Austria

Canada4 sites, 4 recruiting

  • Study site

    Calgary

    Recruiting

  • Study site

    Kingston

    Recruiting

  • Study site

    Montreal

    Recruiting

  • Study site

    Québec

    Recruiting

Other trials in Canada

Israel4 sites, 3 recruiting

  • Study site

    Ashkelon

    Recruiting

  • Study site

    Beersheba

    Terminated

  • Study site

    Jerusalem

    Recruiting

  • Study site

    Ramat Gan

    Recruiting

Other trials in Israel

Sweden4 sites, 3 recruiting

  • Study site

    Gothenburg

    Recruiting

  • Study site

    Lund

    Recruiting

  • Study site

    Skövde

    Recruiting

  • Study site

    Uppsala

    Terminated

Other trials in Sweden

Greece3 sites, 2 recruiting

  • Study site

    Athens

    Recruiting

  • Study site

    Marousi

    Active, not recruiting

  • Study site

    Thessaloniki

    Recruiting

Other trials in Greece

Norway3 sites, 2 recruiting

  • Study site

    Bergen

    Recruiting

  • Study site

    Oslo

    Terminated

  • Study site

    Trondheim

    Recruiting

Other trials in Norway

Poland3 sites, 1 recruiting

  • Study site

    Poznan

    Active, not recruiting

  • Study site

    Warsaw

    Recruiting

  • Study site

    Zabrze

    Active, not recruiting

Other trials in Poland

Kuwait2 sites, 1 recruiting

  • Study site

    Hadiya

    Terminated

  • Study site

    Kuwait City

    Recruiting

Other trials in Kuwait

Saudi Arabia2 sites, 1 recruiting

  • Study site

    Jeddah

    Recruiting

  • Study site

    Riyadh

    Completed

Other trials in Saudi Arabia

Slovakia2 sites, 1 recruiting

  • Study site

    Bratislava

    Recruiting

  • Study site

    Košice

    Terminated

Other trials in Slovakia

Czechia1 site

  • Study site

    Prague

    Active, not recruiting

Other trials in Czechia

Finland1 site, 1 recruiting

  • Study site

    Helsinki

    Recruiting

Other trials in Finland

Hong Kong1 site, 1 recruiting

  • Study site

    Hong Kong

    Recruiting

Other trials in Hong Kong

Hungary1 site, 1 recruiting

  • Study site

    Budapest

    Recruiting

Other trials in Hungary

Iceland1 site

  • Study site

    Reykjavik

    Terminated

Other trials in Iceland

Malaysia1 site, 1 recruiting

  • Study site

    Kuala Lumpur

    Recruiting

Other trials in Malaysia

New Zealand1 site

  • Study site

    Christchurch

    Active, not recruiting

Other trials in New Zealand

Serbia1 site, 1 recruiting

  • Study site

    Belgrade

    Recruiting

Other trials in Serbia

Slovenia1 site

  • Study site

    Ljubljana

    Terminated

Other trials in Slovenia

About this study

Official title: Medtronic CRDM Product Performance Report

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.

Read the detailed description

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Being tested
Device
Keywords
Cardiac Pacing, Implantable Cardioverter Defibrillator, pacemaker, Sinus Bradycardia
Medical subject headings
Arrhythmias, Cardiac, Bradycardia, Heart Failure, Tachycardia, Sinus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeviceDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lead related complications for each lead model.

    All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2005 (estimated)
  2. Study startJan 1983
  3. Primary completionDec 2040 (estimated)
  4. Study completionDec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00271180
Sponsor's protocol ID
602
Acronym
PPR
Status last verified
Aug 2026
First submitted
28 Dec 2005
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

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