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

NCT ID: NCT00271180

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1983-01-31

Study Completion Date

2040-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Arrhythmia Bradycardia Heart Failure Sinus Tachycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Device

Intervention Type DEVICE

Eligibility Criteria

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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 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Product Performance Report Study Leader

Role: STUDY_CHAIR

Medtronic

Locations

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Birmingham, Alabama, United States

Site Status RECRUITING

Anchorage, Alaska, United States

Site Status TERMINATED

Chandler, Arizona, United States

Site Status RECRUITING

Jonesboro, Arkansas, United States

Site Status TERMINATED

Little Rock, Arkansas, United States

Site Status RECRUITING

Bakersfield, California, United States

Site Status TERMINATED

Chula Vista, California, United States

Site Status RECRUITING

La Jolla, California, United States

Site Status RECRUITING

Los Angeles, California, United States

Site Status TERMINATED

Palm Springs, California, United States

Site Status TERMINATED

Rancho Mirage, California, United States

Site Status TERMINATED

Redwood City, California, United States

Site Status ACTIVE_NOT_RECRUITING

Salinas, California, United States

Site Status RECRUITING

San Diego, California, United States

Site Status TERMINATED

Stanford, California, United States

Site Status RECRUITING

Torrance, California, United States

Site Status RECRUITING

Van Nuys, California, United States

Site Status TERMINATED

Ventura, California, United States

Site Status RECRUITING

Aurora, Colorado, United States

Site Status RECRUITING

Centennial, Colorado, United States

Site Status RECRUITING

Colorado Springs, Colorado, United States

Site Status RECRUITING

Denver, Colorado, United States

Site Status TERMINATED

Lakewood, Colorado, United States

Site Status RECRUITING

Hartford, Connecticut, United States

Site Status RECRUITING

New Haven, Connecticut, United States

Site Status RECRUITING

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Bradenton, Florida, United States

Site Status TERMINATED

Clearwater, Florida, United States

Site Status RECRUITING

Hollywood, Florida, United States

Site Status RECRUITING

Jacksonville, Florida, United States

Site Status RECRUITING

Panama City, Florida, United States

Site Status RECRUITING

Safety Harbor, Florida, United States

Site Status RECRUITING

Sarasota, Florida, United States

Site Status RECRUITING

Tampa, Florida, United States

Site Status RECRUITING

Atlanta, Georgia, United States

Site Status RECRUITING

Marietta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Evansville, Indiana, United States

Site Status RECRUITING

Indianapolis, Indiana, United States

Site Status RECRUITING

West Des Moines, Iowa, United States

Site Status RECRUITING

Kansas City, Kansas, United States

Site Status RECRUITING

Edgewood, Kentucky, United States

Site Status RECRUITING

Louisville, Kentucky, United States

Site Status RECRUITING

Baton Rouge, Louisiana, United States

Site Status TERMINATED

Shreveport, Louisiana, United States

Site Status TERMINATED

Baltimore, Maryland, United States

Site Status TERMINATED

Bethesda, Maryland, United States

Site Status RECRUITING

Clinton, Maryland, United States

Site Status TERMINATED

Hyattsville, Maryland, United States

Site Status RECRUITING

Salisbury, Maryland, United States

Site Status RECRUITING

Silver Spring, Maryland, United States

Site Status TERMINATED

Takoma Park, Maryland, United States

Site Status RECRUITING

Boston, Massachusetts, United States

Site Status RECRUITING

Lansing, Michigan, United States

Site Status RECRUITING

Marquette, Michigan, United States

Site Status TERMINATED

Ypsilanti, Michigan, United States

Site Status RECRUITING

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Minneapolis, Minnesota, United States

Site Status RECRUITING

Robbinsdale, Minnesota, United States

Site Status RECRUITING

Rochester, Minnesota, United States

Site Status RECRUITING

Saint Cloud, Minnesota, United States

Site Status RECRUITING

Saint Paul, Minnesota, United States

Site Status TERMINATED

Hattiesburg, Mississippi, United States

Site Status TERMINATED

Columbia, Missouri, United States

Site Status RECRUITING

Kansas City, Missouri, United States

Site Status RECRUITING

St Louis, Missouri, United States

Site Status RECRUITING

Omaha, Nebraska, United States

Site Status RECRUITING

Eatontown, New Jersey, United States

Site Status RECRUITING

Marlton, New Jersey, United States

Site Status RECRUITING

Morristown, New Jersey, United States

Site Status RECRUITING

New Brunswick, New Jersey, United States

Site Status TERMINATED

Ocean City, New Jersey, United States

Site Status RECRUITING

Ridgewood, New Jersey, United States

Site Status RECRUITING

Albuquerque, New Mexico, United States

Site Status RECRUITING

Huntington, New York, United States

Site Status RECRUITING

Manhasset, New York, United States

Site Status ACTIVE_NOT_RECRUITING

New York, New York, United States

Site Status RECRUITING

Poughkeepsie, New York, United States

Site Status RECRUITING

Utica, New York, United States

Site Status RECRUITING

Durham, North Carolina, United States

Site Status RECRUITING

Raleigh, North Carolina, United States

Site Status RECRUITING

Akron, Ohio, United States

Site Status TERMINATED

Cincinnati, Ohio, United States

Site Status RECRUITING

Cleveland, Ohio, United States

Site Status RECRUITING

Columbus, Ohio, United States

Site Status RECRUITING

Toledo, Ohio, United States

Site Status RECRUITING

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Portland, Oregon, United States

Site Status TERMINATED

Allentown, Pennsylvania, United States

Site Status RECRUITING

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Danville, Pennsylvania, United States

Site Status RECRUITING

Erie, Pennsylvania, United States

Site Status RECRUITING

Lancaster, Pennsylvania, United States

Site Status TERMINATED

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Wilkes-Barre, Pennsylvania, United States

Site Status RECRUITING

Columbia, South Carolina, United States

Site Status RECRUITING

Germantown, Tennessee, United States

Site Status RECRUITING

Nashville, Tennessee, United States

Site Status RECRUITING

Austin, Texas, United States

Site Status RECRUITING

Dallas, Texas, United States

Site Status RECRUITING

Fort Worth, Texas, United States

Site Status RECRUITING

Houston, Texas, United States

Site Status TERMINATED

Plano, Texas, United States

Site Status RECRUITING

The Woodlands, Texas, United States

Site Status TERMINATED

Tyler, Texas, United States

Site Status RECRUITING

Burlington, Vermont, United States

Site Status RECRUITING

Charlottesville, Virginia, United States

Site Status RECRUITING

Falls Church, Virginia, United States

Site Status TERMINATED

Olympia, Washington, United States

Site Status RECRUITING

Spokane, Washington, United States

Site Status RECRUITING

Madison, Wisconsin, United States

Site Status RECRUITING

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Chermside, , Australia

Site Status TERMINATED

Douglas, , Australia

Site Status TERMINATED

Murdoch, , Australia

Site Status TERMINATED

Southport, , Australia

Site Status TERMINATED

Graz, , Austria

Site Status RECRUITING

Innsbruck, , Austria

Site Status RECRUITING

Linz, , Austria

Site Status RECRUITING

Vienna, , Austria

Site Status RECRUITING

Bruges, , Belgium

Site Status RECRUITING

Brussels, , Belgium

Site Status RECRUITING

Edegem, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Leuven, , Belgium

Site Status RECRUITING

Liège, , Belgium

Site Status RECRUITING

Yvoir, , Belgium

Site Status TERMINATED

Calgary, , Canada

Site Status RECRUITING

Kingston, , Canada

Site Status RECRUITING

Montreal, , Canada

Site Status RECRUITING

Québec, , Canada

Site Status RECRUITING

Beijing, , China

Site Status RECRUITING

Changsha, , China

Site Status TERMINATED

Dalian, , China

Site Status RECRUITING

Fuzhou, , China

Site Status TERMINATED

Guangzhou, , China

Site Status RECRUITING

Hangzhou, , China

Site Status RECRUITING

Harbin, , China

Site Status RECRUITING

Kunming, , China

Site Status RECRUITING

Nanchang, , China

Site Status RECRUITING

Shanghai, , China

Site Status RECRUITING

Shantou, , China

Site Status TERMINATED

Suzhou, , China

Site Status RECRUITING

Taiyuan, , China

Site Status TERMINATED

Tianjin, , China

Site Status TERMINATED

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Aarhus, , Denmark

Site Status TERMINATED

Copenhagen, , Denmark

Site Status RECRUITING

Hellerup, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Hillerød, , Denmark

Site Status TERMINATED

Odense, , Denmark

Site Status RECRUITING

Helsinki, , Finland

Site Status RECRUITING

Avignon, , France

Site Status RECRUITING

Bayonne, , France

Site Status TERMINATED

Brest, , France

Site Status RECRUITING

Caen, , France

Site Status RECRUITING

Chambray-lès-Tours, , France

Site Status ACTIVE_NOT_RECRUITING

Clermont-Ferrand, , France

Site Status RECRUITING

Dijon, , France

Site Status RECRUITING

La Rochelle, , France

Site Status RECRUITING

La Tronche, , France

Site Status ACTIVE_NOT_RECRUITING

Lille, , France

Site Status ACTIVE_NOT_RECRUITING

Montpellier, , France

Site Status RECRUITING

Nantes, , France

Site Status RECRUITING

Neuilly-sur-Seine, , France

Site Status TERMINATED

Paris, , France

Site Status RECRUITING

Pessac, , France

Site Status ACTIVE_NOT_RECRUITING

Pringy, , France

Site Status RECRUITING

Rennes, , France

Site Status ACTIVE_NOT_RECRUITING

Saint-Priest-en-Jarez, , France

Site Status ACTIVE_NOT_RECRUITING

Strasbourg, , France

Site Status TERMINATED

Toulouse, , France

Site Status ACTIVE_NOT_RECRUITING

Vandœuvre-lès-Nancy, , France

Site Status ACTIVE_NOT_RECRUITING

Villeurbanne, , France

Site Status ACTIVE_NOT_RECRUITING

Aachen, , Germany

Site Status RECRUITING

Bad Oeynhausen, , Germany

Site Status RECRUITING

Bremen, , Germany

Site Status RECRUITING

Cologne, , Germany

Site Status RECRUITING

Dresden, , Germany

Site Status TERMINATED

Düsseldorf, , Germany

Site Status RECRUITING

Essen, , Germany

Site Status TERMINATED

Hamburg, , Germany

Site Status TERMINATED

Hanover, , Germany

Site Status RECRUITING

Heidelberg, , Germany

Site Status TERMINATED

Homburg, , Germany

Site Status TERMINATED

Jena, , Germany

Site Status ACTIVE_NOT_RECRUITING

München, , Germany

Site Status RECRUITING

Münster, , Germany

Site Status ACTIVE_NOT_RECRUITING

Tübingen, , Germany

Site Status TERMINATED

Ulm, , Germany

Site Status RECRUITING

Villingen-Schwenningen, , Germany

Site Status TERMINATED

Athens, , Greece

Site Status RECRUITING

Marousi, , Greece

Site Status ACTIVE_NOT_RECRUITING

Thessaloniki, , Greece

Site Status RECRUITING

Hong Kong, , Hong Kong

Site Status RECRUITING

Budapest, , Hungary

Site Status RECRUITING

Reykjavik, , Iceland

Site Status TERMINATED

Bangalore, , India

Site Status RECRUITING

Gūrgaon, , India

Site Status RECRUITING

Jaipur, , India

Site Status RECRUITING

Kochi, , India

Site Status RECRUITING

New Delhi, , India

Site Status RECRUITING

Ashkelon, , Israel

Site Status RECRUITING

Beersheba, , Israel

Site Status TERMINATED

Jerusalem, , Israel

Site Status RECRUITING

Ramat Gan, , Israel

Site Status RECRUITING

Ancona, , Italy

Site Status TERMINATED

Bari, , Italy

Site Status RECRUITING

Bologna, , Italy

Site Status ACTIVE_NOT_RECRUITING

Brescia, , Italy

Site Status ACTIVE_NOT_RECRUITING

Castrovillari, , Italy

Site Status RECRUITING

Cotignola, , Italy

Site Status ACTIVE_NOT_RECRUITING

Lecce, , Italy

Site Status RECRUITING

Milan, , Italy

Site Status RECRUITING

Monza, , Italy

Site Status RECRUITING

Pisa, , Italy

Site Status ACTIVE_NOT_RECRUITING

Taranto, , Italy

Site Status RECRUITING

Udine, , Italy

Site Status RECRUITING

Ageo, , Japan

Site Status RECRUITING

Bunkyō City, , Japan

Site Status RECRUITING

Gifu, , Japan

Site Status RECRUITING

Hidaka, , Japan

Site Status RECRUITING

Hiroshima, , Japan

Site Status RECRUITING

Kagoshima, , Japan

Site Status RECRUITING

Kamakura, , Japan

Site Status RECRUITING

Kawasaki, , Japan

Site Status RECRUITING

Kitakyushu, , Japan

Site Status RECRUITING

Koshigaya, , Japan

Site Status RECRUITING

Kumamoto, , Japan

Site Status RECRUITING

Kyoto, , Japan

Site Status RECRUITING

Mitaka, , Japan

Site Status RECRUITING

Nagoya, , Japan

Site Status RECRUITING

Niigata, , Japan

Site Status RECRUITING

Okayama, , Japan

Site Status RECRUITING

Ōsaka-sayama, , Japan

Site Status TERMINATED

Sapporo, , Japan

Site Status RECRUITING

Shinagawa-Ku, , Japan

Site Status RECRUITING

Shizuoka, , Japan

Site Status RECRUITING

Suita, , Japan

Site Status RECRUITING

Tokyo, , Japan

Site Status TERMINATED

Toyoake, , Japan

Site Status RECRUITING

Tsukuba, , Japan

Site Status RECRUITING

Urasoe, , Japan

Site Status RECRUITING

Yamagata, , Japan

Site Status TERMINATED

Yokohama, , Japan

Site Status RECRUITING

Hadiya, , Kuwait

Site Status TERMINATED

Kuwait City, , Kuwait

Site Status RECRUITING

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Amsterdam, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Breda, , Netherlands

Site Status TERMINATED

Eindhoven, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Enschede, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Groningen, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Leiden, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Maastricht, , Netherlands

Site Status RECRUITING

Nieuwegein, , Netherlands

Site Status RECRUITING

Rotterdam, , Netherlands

Site Status RECRUITING

The Hague, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Christchurch, , New Zealand

Site Status ACTIVE_NOT_RECRUITING

Bergen, , Norway

Site Status RECRUITING

Oslo, , Norway

Site Status TERMINATED

Trondheim, , Norway

Site Status RECRUITING

Poznan, , Poland

Site Status ACTIVE_NOT_RECRUITING

Warsaw, , Poland

Site Status RECRUITING

Zabrze, , Poland

Site Status ACTIVE_NOT_RECRUITING

Carnaxide, , Portugal

Site Status RECRUITING

Creixomil, , Portugal

Site Status RECRUITING

Lisbon, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Porto, , Portugal

Site Status RECRUITING

Santarém, , Portugal

Site Status RECRUITING

Jeddah, , Saudi Arabia

Site Status RECRUITING

Riyadh, , Saudi Arabia

Site Status ACTIVE_NOT_RECRUITING

Belgrade, , Serbia

Site Status RECRUITING

Bratislava, , Slovakia

Site Status RECRUITING

Košice, , Slovakia

Site Status TERMINATED

Ljubljana, , Slovenia

Site Status TERMINATED

Cheongju-si, , South Korea

Site Status RECRUITING

Daejeon, , South Korea

Site Status RECRUITING

Gyeonggi-do, , South Korea

Site Status RECRUITING

Seoul, , South Korea

Site Status RECRUITING

Suwon, , South Korea

Site Status RECRUITING

A Coruña, , Spain

Site Status RECRUITING

Barcelona, , Spain

Site Status RECRUITING

Córdoba, , Spain

Site Status RECRUITING

Girona, , Spain

Site Status RECRUITING

Granada, , Spain

Site Status RECRUITING

Madrid, , Spain

Site Status RECRUITING

Palma de Mallorca, , Spain

Site Status RECRUITING

Salamanca, , Spain

Site Status RECRUITING

Santa Cruz de Tenerife, , Spain

Site Status RECRUITING

Santiago de Compostela, , Spain

Site Status RECRUITING

Toledo, , Spain

Site Status RECRUITING

Valencia, , Spain

Site Status RECRUITING

Valladolid, , Spain

Site Status RECRUITING

Vitoria-Gasteiz, , Spain

Site Status ACTIVE_NOT_RECRUITING

Gothenburg, , Sweden

Site Status RECRUITING

Lund, , Sweden

Site Status RECRUITING

Skövde, , Sweden

Site Status RECRUITING

Uppsala, , Sweden

Site Status TERMINATED

Basel, , Switzerland

Site Status RECRUITING

Bern, , Switzerland

Site Status RECRUITING

Fribourg, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Geneva, , Switzerland

Site Status RECRUITING

Lausanne, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Lugano, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Zurich, , Switzerland

Site Status RECRUITING

Birmingham, , United Kingdom

Site Status RECRUITING

Blackpool, , United Kingdom

Site Status RECRUITING

Bristol, , United Kingdom

Site Status RECRUITING

Leeds, , United Kingdom

Site Status RECRUITING

Leicester, , United Kingdom

Site Status RECRUITING

Liverpool, , United Kingdom

Site Status RECRUITING

London, , United Kingdom

Site Status RECRUITING

Manchester, , United Kingdom

Site Status RECRUITING

Middlesbrough, , United Kingdom

Site Status RECRUITING

Northampton, , United Kingdom

Site Status RECRUITING

Nottingham, , United Kingdom

Site Status TERMINATED

Sheffield, , United Kingdom

Site Status RECRUITING

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Austria Belgium Canada China Czechia Denmark Finland France Germany Greece Hong Kong Hungary Iceland India Israel Italy Japan Kuwait Malaysia Netherlands New Zealand Norway Poland Portugal Saudi Arabia Serbia Slovakia Slovenia South Korea Spain Sweden Switzerland United Kingdom

Central Contacts

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Medtronic CRM Clinical Trials

Role: CONTACT

Other Identifiers

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602

Identifier Type: -

Identifier Source: org_study_id