Clinical trial NCT00271180: Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Official title: Medtronic CRDM Product Performance Report
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmia
Bradycardia
Heart Failure
Sinus Tachycardia
Keywords: Cardiac Pacing
Implantable Cardioverter Defibrillator
pacemaker
Sinus Bradycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2005-12-30
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects implanted with Medtronic qualifying cardiac rhythm product.

Brief 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: 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

Primary outcomes:
measure: Lead related complications for each lead model.
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Chandler
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Redwood City
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
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state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Centennial
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state: Colorado
city: Colorado Springs
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state: Colorado
city: Denver
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state: Colorado
city: Lakewood
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state: Colorado
city: Hartford
country: United States
state: Connecticut
city: New Haven
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state: Connecticut
city: Washington
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state: District of Columbia
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city: Clearwater
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city: Hollywood
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city: Jacksonville
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city: Panama City
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city: Marietta
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state: Kentucky
city: Louisville
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city: Bethesda
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city: Clinton
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state: Maryland
city: Takoma Park
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city: Hattiesburg
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state: Mississippi
city: Columbia
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state: Missouri
city: Kansas City
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state: Missouri
city: Saint Louis
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state: Missouri
city: Omaha
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state: Nebraska
city: Marlton
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city: Morristown
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city: New Brunswick
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city: Ocean
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city: Ridgewood
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city: Albuquerque
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state: New Mexico
city: Huntington
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state: New York
city: Manhasset
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state: New York
city: New York
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city: Poughkeepsie
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state: New York
city: Utica
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state: New York
city: Durham
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Akron
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state: Ohio
city: Cincinnati
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state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Bethlehem
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state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Pittsburgh
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state: Pennsylvania
city: Wilkes-Barre
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Chermside
country: Australia
city: Douglas
country: Australia
city: Murdoch
country: Australia
city: Southport
country: Australia
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Brugge
country: Belgium
city: Brussel
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Yvoir
country: Belgium
city: Calgary
country: Canada
city: Kingston
country: Canada
city: Montreal
country: Canada
city: Québec
country: Canada
city: Beijing
country: China
city: Changsha
country: China
city: Dalian
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Kunming
country: China
city: Nanchang
country: China
city: Shanghai
country: China
city: Shantou
country: China
city: Suzhou
country: China
city: Taiyuan
country: China
city: Tianjin
country: China
city: Praha
country: Czechia
city: Copenhagen
country: Denmark
city: Hellerup
country: Denmark
city: Hillerød
country: Denmark
city: Odense
country: Denmark
city: Århus
country: Denmark
city: Helsinki
country: Finland
city: Avignon
country: France
city: Bayonne
country: France
city: Brest
country: France
city: Caen
country: France
city: Chambray-lès-Tours
country: France
city: Clermont-Ferrand
country: France
city: Dijon
country: France
city: La Rochelle
country: France
city: La Tronche
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city: Lille
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Neuilly-sur-Seine
country: France
city: Paris
country: France
city: Pessac
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city: Pringy
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city: Rennes
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city: Saint-Priest-en-Jarez
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city: Strasbourg
country: France
city: Toulouse
country: France
city: Vandoeuvre les Nancy
country: France
city: Villeurbanne
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city: Aachen
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city: Bad Oeynhausen
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city: Bremen
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city: Dresden
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city: Düsseldorf
country: Germany
city: Essen
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city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
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city: Homburg
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city: Jena
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city: Köln
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Tübingen
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city: Ulm
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city: Villingen-Schwenningen
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city: Athens
country: Greece
city: Marousi
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city: Thessaloníki
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city: Gurgaon
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city: Be'er Sheva
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city: Jerusalem
country: Israel
city: Ramat Gan
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city: Ancona
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city: Bari
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city: Bologna
country: Italy
city: Brescia
country: Italy
city: Castrovillari
country: Italy
city: Cotignola
country: Italy
city: Lecce
country: Italy
city: Milano
country: Italy
city: Monza
country: Italy
city: Pisa
country: Italy
city: Taranto
country: Italy
city: Udine
country: Italy
city: Ageo
country: Japan
city: Gifu
country: Japan
city: Hidaka
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city: Hiroshima City
country: Japan
city: Kagoshima
country: Japan
city: Kamakura
country: Japan
city: Kawasaki
country: Japan
city: Kitakyushu
country: Japan
city: Koshigaya
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Mitaka
country: Japan
city: Nagoya
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Sapporo
country: Japan
city: Shinagawa-Ku
country: Japan
city: Shizuoka
country: Japan
city: Suita
country: Japan
city: Tokyo
country: Japan
city: Toyoake
country: Japan
city: Urasoe
country: Japan
city: Yamagata
country: Japan
city: Yokohama
country: Japan
city: Ōsaka-sayama
country: Japan
city: Cheongju-si
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon-si
country: Korea, Republic of
city: Hadiya
country: Kuwait
city: Kuwait
country: Kuwait
city: Kuala Lumpur
country: Malaysia
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Den Haag
country: Netherlands
city: Eindhoven
country: Netherlands
city: Enschede
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Christchurch
country: New Zealand
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Trondheim
country: Norway
city: Poznań
country: Poland
city: Warsaw
country: Poland
city: Zabrze
country: Poland
city: Carnaxide
country: Portugal
city: Creixomil
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Santarém
country: Portugal
city: Jeddah
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
city: Belgrade
country: Serbia
city: Bratislava
country: Slovakia
city: Košice
country: Slovakia
city: Ljubljana
country: Slovenia
city: A Coruña
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Palma De Mallorca
country: Spain
city: Salamanca
country: Spain
city: Santa Cruz De Tenerife
country: Spain
city: Santiago de Compostela
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Vitoria-Gasteiz
country: Spain
city: Göteborg
country: Sweden
city: Göteborg
country: Sweden
city: Lund
country: Sweden
city: Skövde
country: Sweden
city: Uppsala
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Fribourg
country: Switzerland
city: Geneva
country: Switzerland
city: Lausanne
country: Switzerland
city: Lugano
country: Switzerland
city: Zürich
country: Switzerland
city: Birmingham
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Bristol
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Northampton
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Medtronic
name: Product Performance Report Study Leader
role: STUDY_CHAIR
References: