NCT00271180Recruiting

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

Medtronic

Start Date

1/1/1983

Completion Date

12/1/2040

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.

Detailed Description

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

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DEVICE

Device

Interested in This Trial?

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Conditions

ArrhythmiaBradycardiaHeart FailureSinus Tachycardia

Locations

Birmingham, Alabama

United States

Anchorage, Alaska

United States

Chandler, Arizona

United States

Jonesboro, Arkansas

United States

Little Rock, Arkansas

United States

Bakersfield, California

United States

Chula Vista, California

United States

La Jolla, California

United States

Los Angeles, California

United States

Palm Springs, California

United States

Rancho Mirage, California

United States

Redwood City, California

United States

Salinas, California

United States

San Diego, California

United States

Stanford, California

United States

Torrance, California

United States

Van Nuys, California

United States

Ventura, California

United States

Aurora, Colorado

United States

Centennial, Colorado

United States

Colorado Springs, Colorado

United States

Denver, Colorado

United States

Lakewood, Colorado

United States

Hartford, Connecticut

United States

New Haven, Connecticut

United States

Washington D.C., District of Columbia

United States

Bradenton, Florida

United States

Clearwater, Florida

United States

Hollywood, Florida

United States

Jacksonville, Florida

United States

Panama City, Florida

United States

Safety Harbor, Florida

United States

Sarasota, Florida

United States

Tampa, Florida

United States

Atlanta, Georgia

United States

Marietta, Georgia

United States

Evansville, Indiana

United States

Indianapolis, Indiana

United States

West Des Moines, Iowa

United States

Kansas City, Kansas

United States

Edgewood, Kentucky

United States

Louisville, Kentucky

United States

Baton Rouge, Louisiana

United States

Shreveport, Louisiana

United States

Baltimore, Maryland

United States

Bethesda, Maryland

United States

Clinton, Maryland

United States

Hyattsville, Maryland

United States

Salisbury, Maryland

United States

Silver Spring, Maryland

United States

Takoma Park, Maryland

United States

Boston, Massachusetts

United States

Lansing, Michigan

United States

Marquette, Michigan

United States

Ypsilanti, Michigan

United States

Coon Rapids, Minnesota

United States

Minneapolis, Minnesota

United States

Robbinsdale, Minnesota

United States

Rochester, Minnesota

United States

Saint Cloud, Minnesota

United States

Saint Paul, Minnesota

United States

Hattiesburg, Mississippi

United States

Columbia, Missouri

United States

Kansas City, Missouri

United States

St Louis, Missouri

United States

Omaha, Nebraska

United States

Eatontown, New Jersey

United States

Marlton, New Jersey

United States

Morristown, New Jersey

United States

New Brunswick, New Jersey

United States

Ocean City, New Jersey

United States

Ridgewood, New Jersey

United States

Albuquerque, New Mexico

United States

Huntington, New York

United States

Manhasset, New York

United States

New York, New York

United States

Port Jefferson, New York

United States

Poughkeepsie, New York

United States

Utica, New York

United States

Durham, North Carolina

United States

Raleigh, North Carolina

United States

Akron, Ohio

United States

Cincinnati, Ohio

United States

Cleveland, Ohio

United States

Columbus, Ohio

United States

Toledo, Ohio

United States

Oklahoma City, Oklahoma

United States

Portland, Oregon

United States

Allentown, Pennsylvania

United States

Bethlehem, Pennsylvania

United States

Danville, Pennsylvania

United States

Erie, Pennsylvania

United States

Lancaster, Pennsylvania

United States

Philadelphia, Pennsylvania

United States

Pittsburgh, Pennsylvania

United States

Wilkes-Barre, Pennsylvania

United States

Columbia, South Carolina

United States

Germantown, Tennessee

United States

Nashville, Tennessee

United States

Austin, Texas

United States

Dallas, Texas

United States

Fort Worth, Texas

United States

Houston, Texas

United States

Plano, Texas

United States

The Woodlands, Texas

United States

Tyler, Texas

United States

Burlington, Vermont

United States

Charlottesville, Virginia

United States

Falls Church, Virginia

United States

Olympia, Washington

United States

Spokane, Washington

United States

Madison, Wisconsin

United States

Milwaukee, Wisconsin

United States

Chermside,

Australia

Douglas,

Australia

Murdoch,

Australia

Southport,

Australia

Graz,

Austria

Innsbruck,

Austria

Linz,

Austria

Vienna,

Austria

Bruges,

Belgium

Brussels,

Belgium

Edegem,

Belgium

Leuven,

Belgium

Liège,

Belgium

Yvoir,

Belgium

Calgary,

Canada

Kingston,

Canada

Montreal,

Canada

Québec,

Canada

Beijing,

China

Changsha,

China

Dalian,

China

Fuzhou,

China

Guangzhou,

China

Hangzhou,

China

Harbin,

China

Kunming,

China

Nanchang,

China

Nanjing,

China

Shanghai,

China

Shantou,

China

Suzhou,

China

Taiyuan,

China

Tianjin,

China

Prague,

Czechia

Aarhus,

Denmark

Copenhagen,

Denmark

Hellerup,

Denmark

Hillerød,

Denmark

Odense,

Denmark

Helsinki,

Finland

Avignon,

France

Bayonne,

France

Brest,

France

Caen,

France

Chambray-lès-Tours,

France

Clermont-Ferrand,

France

Dijon,

France

La Rochelle,

France

La Tronche,

France

Lille,

France

Montpellier,

France

Nantes,

France

Neuilly-sur-Seine,

France

Paris,

France

Pessac,

France

Pringy,

France

Rennes,

France

Saint-Priest-en-Jarez,

France

Strasbourg,

France

Toulouse,

France

Vandœuvre-lès-Nancy,

France

Villeurbanne,

France

Aachen,

Germany

Bad Oeynhausen,

Germany

Bremen,

Germany

Cologne,

Germany

Dresden,

Germany

Düsseldorf,

Germany

Essen,

Germany

Hamburg,

Germany

Hanover,

Germany

Heidelberg,

Germany

Homburg,

Germany

Jena,

Germany

München,

Germany

Münster,

Germany

Tübingen,

Germany

Ulm,

Germany

Villingen-Schwenningen,

Germany

Athens,

Greece

Marousi,

Greece

Thessaloniki,

Greece

Hong Kong,

Hong Kong

Budapest,

Hungary

Reykjavik,

Iceland

Bangalore,

India

Gurgaon,

India

Jaipur,

India

Kochi,

India

New Delhi,

India

Ashkelon,

Israel

Beersheba,

Israel

Jerusalem,

Israel

Ramat Gan,

Israel

Ancona,

Italy

Bari,

Italy

Bologna,

Italy

Brescia,

Italy

Castrovillari,

Italy

Cotignola,

Italy

Lecce,

Italy

Milan,

Italy

Monza,

Italy

Pisa,

Italy

Taranto,

Italy

Udine,

Italy

Ageo,

Japan

Bunkyō City,

Japan

Gifu,

Japan

Hidaka,

Japan

Hiroshima,

Japan

Kagoshima,

Japan

Kamakura,

Japan

Kawasaki,

Japan

Kitakyushu,

Japan

Koshigaya,

Japan

Kumamoto,

Japan

Kyoto,

Japan

Mitaka,

Japan

Nagoya,

Japan

Niigata,

Japan

Okayama,

Japan

Ōsaka-sayama,

Japan

Sapporo,

Japan

Shinagawa-Ku,

Japan

Shizuoka,

Japan

Suita,

Japan

Tokyo,

Japan

Toyoake,

Japan

Tsukuba,

Japan

Urasoe,

Japan

Yamagata,

Japan

Yokohama,

Japan

Hadiya,

Kuwait

Kuwait City,

Kuwait

Kuala Lumpur,

Malaysia

Amsterdam,

Netherlands

Breda,

Netherlands

Eindhoven,

Netherlands

Enschede,

Netherlands

Groningen,

Netherlands

Leiden,

Netherlands

Maastricht,

Netherlands

Nieuwegein,

Netherlands

Rotterdam,

Netherlands

The Hague,

Netherlands

Christchurch,

New Zealand

Bergen,

Norway

Oslo,

Norway

Trondheim,

Norway

Poznan,

Poland

Warsaw,

Poland

Zabrze,

Poland

Carnaxide,

Portugal

Creixomil,

Portugal

Lisbon,

Portugal

Porto,

Portugal

Santarém,

Portugal

Jeddah,

Saudi Arabia

Riyadh,

Saudi Arabia

Belgrade,

Serbia

Bratislava,

Slovakia

Košice,

Slovakia

Ljubljana,

Slovenia

Cheongju-si,

South Korea

Daejeon,

South Korea

Gyeonggi-do,

South Korea

Seoul,

South Korea

Suwon,

South Korea

A Coruña,

Spain

Barcelona,

Spain

Córdoba,

Spain

Girona,

Spain

Granada,

Spain

Madrid,

Spain

Palma de Mallorca,

Spain

Salamanca,

Spain

Santa Cruz de Tenerife,

Spain

Santiago de Compostela,

Spain

Toledo,

Spain

Valencia,

Spain

Valladolid,

Spain

Vitoria-Gasteiz,

Spain

Gothenburg,

Sweden

Lund,

Sweden

Skövde,

Sweden

Uppsala,

Sweden

Basel,

Switzerland

Bern,

Switzerland

Fribourg,

Switzerland

Geneva,

Switzerland

Lausanne,

Switzerland

Lugano,

Switzerland

Zurich,

Switzerland

Birmingham,

United Kingdom

Blackpool,

United Kingdom

Bristol,

United Kingdom

Leeds,

United Kingdom

Leicester,

United Kingdom

Liverpool,

United Kingdom

London,

United Kingdom

Manchester,

United Kingdom

Middlesbrough,

United Kingdom

Northampton,

United Kingdom

Nottingham,

United Kingdom

Sheffield,

United Kingdom

Southampton,

United Kingdom