Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00271180




Registration number
NCT00271180
Ethics application status
Date submitted
28/12/2005
Date registered
30/12/2005
Date last updated
15/10/2024

Titles & IDs
Public title
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Scientific title
Medtronic CRDM Product Performance Report
Secondary ID [1] 0 0
602
Universal Trial Number (UTN)
Trial acronym
PPR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmia 0 0
Bradycardia 0 0
Heart Failure 0 0
Sinus Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lead related complications for each lead model.
Timepoint [1] 0 0
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).

Eligibility
Key inclusion criteria
Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.



• 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/1983
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2040
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Chermside
Recruitment hospital [2] 0 0
- Douglas
Recruitment hospital [3] 0 0
- Murdoch
Recruitment hospital [4] 0 0
- Southport
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Douglas
Recruitment postcode(s) [3] 0 0
- Murdoch
Recruitment postcode(s) [4] 0 0
- Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oklahoma
Country [29] 0 0
United States of America
State/province [29] 0 0
Oregon
Country [30] 0 0
United States of America
State/province [30] 0 0
Pennsylvania
Country [31] 0 0
United States of America
State/province [31] 0 0
South Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Vermont
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
Wisconsin
Country [38] 0 0
Austria
State/province [38] 0 0
Graz
Country [39] 0 0
Austria
State/province [39] 0 0
Innsbruck
Country [40] 0 0
Austria
State/province [40] 0 0
Linz
Country [41] 0 0
Austria
State/province [41] 0 0
Wien
Country [42] 0 0
Belgium
State/province [42] 0 0
Brugge
Country [43] 0 0
Belgium
State/province [43] 0 0
Brussel
Country [44] 0 0
Belgium
State/province [44] 0 0
Edegem
Country [45] 0 0
Belgium
State/province [45] 0 0
Leuven
Country [46] 0 0
Belgium
State/province [46] 0 0
Liège
Country [47] 0 0
Belgium
State/province [47] 0 0
Yvoir
Country [48] 0 0
Canada
State/province [48] 0 0
Calgary
Country [49] 0 0
Canada
State/province [49] 0 0
Kingston
Country [50] 0 0
Canada
State/province [50] 0 0
Montreal
Country [51] 0 0
Canada
State/province [51] 0 0
Québec
Country [52] 0 0
China
State/province [52] 0 0
Beijing
Country [53] 0 0
China
State/province [53] 0 0
Changsha
Country [54] 0 0
China
State/province [54] 0 0
Dalian
Country [55] 0 0
China
State/province [55] 0 0
Fuzhou
Country [56] 0 0
China
State/province [56] 0 0
Guangzhou
Country [57] 0 0
China
State/province [57] 0 0
Hangzhou
Country [58] 0 0
China
State/province [58] 0 0
Harbin
Country [59] 0 0
China
State/province [59] 0 0
Kunming
Country [60] 0 0
China
State/province [60] 0 0
Nanchang
Country [61] 0 0
China
State/province [61] 0 0
Shanghai
Country [62] 0 0
China
State/province [62] 0 0
Shantou
Country [63] 0 0
China
State/province [63] 0 0
Suzhou
Country [64] 0 0
China
State/province [64] 0 0
Taiyuan
Country [65] 0 0
China
State/province [65] 0 0
Tianjin
Country [66] 0 0
Czechia
State/province [66] 0 0
Praha
Country [67] 0 0
Denmark
State/province [67] 0 0
Copenhagen
Country [68] 0 0
Denmark
State/province [68] 0 0
Hellerup
Country [69] 0 0
Denmark
State/province [69] 0 0
Hillerød
Country [70] 0 0
Denmark
State/province [70] 0 0
Odense
Country [71] 0 0
Denmark
State/province [71] 0 0
Århus
Country [72] 0 0
Finland
State/province [72] 0 0
Helsinki
Country [73] 0 0
France
State/province [73] 0 0
Avignon
Country [74] 0 0
France
State/province [74] 0 0
Bayonne
Country [75] 0 0
France
State/province [75] 0 0
Brest
Country [76] 0 0
France
State/province [76] 0 0
Caen
Country [77] 0 0
France
State/province [77] 0 0
Chambray-lès-Tours
Country [78] 0 0
France
State/province [78] 0 0
Clermont-Ferrand
Country [79] 0 0
France
State/province [79] 0 0
Dijon
Country [80] 0 0
France
State/province [80] 0 0
La Rochelle
Country [81] 0 0
France
State/province [81] 0 0
La Tronche
Country [82] 0 0
France
State/province [82] 0 0
Lille
Country [83] 0 0
France
State/province [83] 0 0
Montpellier
Country [84] 0 0
France
State/province [84] 0 0
Nantes
Country [85] 0 0
France
State/province [85] 0 0
Neuilly-sur-Seine
Country [86] 0 0
France
State/province [86] 0 0
Paris
Country [87] 0 0
France
State/province [87] 0 0
Pessac
Country [88] 0 0
France
State/province [88] 0 0
Pringy
Country [89] 0 0
France
State/province [89] 0 0
Rennes
Country [90] 0 0
France
State/province [90] 0 0
Saint-Priest-en-Jarez
Country [91] 0 0
France
State/province [91] 0 0
Strasbourg
Country [92] 0 0
France
State/province [92] 0 0
Toulouse
Country [93] 0 0
France
State/province [93] 0 0
Vandoeuvre les Nancy
Country [94] 0 0
France
State/province [94] 0 0
Villeurbanne
Country [95] 0 0
Germany
State/province [95] 0 0
Aachen
Country [96] 0 0
Germany
State/province [96] 0 0
Bad Oeynhausen
Country [97] 0 0
Germany
State/province [97] 0 0
Bremen
Country [98] 0 0
Germany
State/province [98] 0 0
Dresden
Country [99] 0 0
Germany
State/province [99] 0 0
Düsseldorf
Country [100] 0 0
Germany
State/province [100] 0 0
Essen
Country [101] 0 0
Germany
State/province [101] 0 0
Hamburg
Country [102] 0 0
Germany
State/province [102] 0 0
Hannover
Country [103] 0 0
Germany
State/province [103] 0 0
Heidelberg
Country [104] 0 0
Germany
State/province [104] 0 0
Homburg
Country [105] 0 0
Germany
State/province [105] 0 0
Jena
Country [106] 0 0
Germany
State/province [106] 0 0
Köln
Country [107] 0 0
Germany
State/province [107] 0 0
München
Country [108] 0 0
Germany
State/province [108] 0 0
Münster
Country [109] 0 0
Germany
State/province [109] 0 0
Tübingen
Country [110] 0 0
Germany
State/province [110] 0 0
Ulm
Country [111] 0 0
Greece
State/province [111] 0 0
Athens
Country [112] 0 0
Greece
State/province [112] 0 0
Marousi
Country [113] 0 0
Greece
State/province [113] 0 0
Thessaloníki
Country [114] 0 0
Hong Kong
State/province [114] 0 0
Hong Kong
Country [115] 0 0
Hungary
State/province [115] 0 0
Budapest
Country [116] 0 0
Iceland
State/province [116] 0 0
Reykjavik
Country [117] 0 0
India
State/province [117] 0 0
Bangalore
Country [118] 0 0
India
State/province [118] 0 0
Gurgaon
Country [119] 0 0
India
State/province [119] 0 0
New Delhi
Country [120] 0 0
Israel
State/province [120] 0 0
Ashkelon
Country [121] 0 0
Israel
State/province [121] 0 0
Be'er Sheva
Country [122] 0 0
Israel
State/province [122] 0 0
Jerusalem
Country [123] 0 0
Israel
State/province [123] 0 0
Ramat Gan
Country [124] 0 0
Italy
State/province [124] 0 0
Ancona
Country [125] 0 0
Italy
State/province [125] 0 0
Bari
Country [126] 0 0
Italy
State/province [126] 0 0
Bologna
Country [127] 0 0
Italy
State/province [127] 0 0
Brescia
Country [128] 0 0
Italy
State/province [128] 0 0
Castrovillari
Country [129] 0 0
Italy
State/province [129] 0 0
Cotignola
Country [130] 0 0
Italy
State/province [130] 0 0
Lecce
Country [131] 0 0
Italy
State/province [131] 0 0
Milano
Country [132] 0 0
Italy
State/province [132] 0 0
Pisa
Country [133] 0 0
Italy
State/province [133] 0 0
Taranto
Country [134] 0 0
Italy
State/province [134] 0 0
Udine
Country [135] 0 0
Japan
State/province [135] 0 0
Ageo
Country [136] 0 0
Japan
State/province [136] 0 0
Gifu
Country [137] 0 0
Japan
State/province [137] 0 0
Hidaka
Country [138] 0 0
Japan
State/province [138] 0 0
Hiroshima City
Country [139] 0 0
Japan
State/province [139] 0 0
Kagoshima
Country [140] 0 0
Japan
State/province [140] 0 0
Kamakura
Country [141] 0 0
Japan
State/province [141] 0 0
Kawasaki
Country [142] 0 0
Japan
State/province [142] 0 0
Kitakyushu
Country [143] 0 0
Japan
State/province [143] 0 0
Koshigaya
Country [144] 0 0
Japan
State/province [144] 0 0
Kyoto
Country [145] 0 0
Japan
State/province [145] 0 0
Mitaka
Country [146] 0 0
Japan
State/province [146] 0 0
Nagoya
Country [147] 0 0
Japan
State/province [147] 0 0
Niigata
Country [148] 0 0
Japan
State/province [148] 0 0
Okayama
Country [149] 0 0
Japan
State/province [149] 0 0
Sapporo
Country [150] 0 0
Japan
State/province [150] 0 0
Shinagawa-Ku
Country [151] 0 0
Japan
State/province [151] 0 0
Shizuoka
Country [152] 0 0
Japan
State/province [152] 0 0
Suita
Country [153] 0 0
Japan
State/province [153] 0 0
Tokyo
Country [154] 0 0
Japan
State/province [154] 0 0
Toyoake
Country [155] 0 0
Japan
State/province [155] 0 0
Urasoe
Country [156] 0 0
Japan
State/province [156] 0 0
Yamagata
Country [157] 0 0
Japan
State/province [157] 0 0
Yokohama
Country [158] 0 0
Japan
State/province [158] 0 0
Osaka-sayama
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Cheongju-si
Country [160] 0 0
Korea, Republic of
State/province [160] 0 0
Daejeon
Country [161] 0 0
Korea, Republic of
State/province [161] 0 0
Gyeonggi-do
Country [162] 0 0
Korea, Republic of
State/province [162] 0 0
Seoul
Country [163] 0 0
Korea, Republic of
State/province [163] 0 0
Suwon-si
Country [164] 0 0
Kuwait
State/province [164] 0 0
Hadiya
Country [165] 0 0
Kuwait
State/province [165] 0 0
Kuwait
Country [166] 0 0
Malaysia
State/province [166] 0 0
Kuala Lumpur
Country [167] 0 0
Netherlands
State/province [167] 0 0
Amsterdam
Country [168] 0 0
Netherlands
State/province [168] 0 0
Breda
Country [169] 0 0
Netherlands
State/province [169] 0 0
Den Haag
Country [170] 0 0
Netherlands
State/province [170] 0 0
Eindhoven
Country [171] 0 0
Netherlands
State/province [171] 0 0
Enschede
Country [172] 0 0
Netherlands
State/province [172] 0 0
Groningen
Country [173] 0 0
Netherlands
State/province [173] 0 0
Leiden
Country [174] 0 0
Netherlands
State/province [174] 0 0
Maastricht
Country [175] 0 0
Netherlands
State/province [175] 0 0
Nieuwegein
Country [176] 0 0
Netherlands
State/province [176] 0 0
Rotterdam
Country [177] 0 0
New Zealand
State/province [177] 0 0
Christchurch
Country [178] 0 0
Norway
State/province [178] 0 0
Bergen
Country [179] 0 0
Norway
State/province [179] 0 0
Oslo
Country [180] 0 0
Norway
State/province [180] 0 0
Trondheim
Country [181] 0 0
Poland
State/province [181] 0 0
Poznan
Country [182] 0 0
Poland
State/province [182] 0 0
Warsaw
Country [183] 0 0
Poland
State/province [183] 0 0
Zabrze
Country [184] 0 0
Portugal
State/province [184] 0 0
Carnaxide
Country [185] 0 0
Portugal
State/province [185] 0 0
Creixomil
Country [186] 0 0
Portugal
State/province [186] 0 0
Lisboa
Country [187] 0 0
Portugal
State/province [187] 0 0
Porto
Country [188] 0 0
Portugal
State/province [188] 0 0
Santarém
Country [189] 0 0
Saudi Arabia
State/province [189] 0 0
Jeddah
Country [190] 0 0
Saudi Arabia
State/province [190] 0 0
Riyadh
Country [191] 0 0
Serbia
State/province [191] 0 0
Belgrade
Country [192] 0 0
Slovakia
State/province [192] 0 0
Bratislava
Country [193] 0 0
Slovakia
State/province [193] 0 0
Košice
Country [194] 0 0
Slovenia
State/province [194] 0 0
Ljubljana
Country [195] 0 0
Spain
State/province [195] 0 0
A Coruña
Country [196] 0 0
Spain
State/province [196] 0 0
Barcelona
Country [197] 0 0
Spain
State/province [197] 0 0
Córdoba
Country [198] 0 0
Spain
State/province [198] 0 0
Girona
Country [199] 0 0
Spain
State/province [199] 0 0
Granada
Country [200] 0 0
Spain
State/province [200] 0 0
Madrid
Country [201] 0 0
Spain
State/province [201] 0 0
Palma De Mallorca
Country [202] 0 0
Spain
State/province [202] 0 0
Salamanca
Country [203] 0 0
Spain
State/province [203] 0 0
Santa Cruz De Tenerife
Country [204] 0 0
Spain
State/province [204] 0 0
Santiago de Compostela
Country [205] 0 0
Spain
State/province [205] 0 0
Toledo
Country [206] 0 0
Spain
State/province [206] 0 0
Valencia
Country [207] 0 0
Spain
State/province [207] 0 0
Valladolid
Country [208] 0 0
Spain
State/province [208] 0 0
Vitoria-Gasteiz
Country [209] 0 0
Sweden
State/province [209] 0 0
Göteborg
Country [210] 0 0
Sweden
State/province [210] 0 0
Lund
Country [211] 0 0
Sweden
State/province [211] 0 0
Skövde
Country [212] 0 0
Sweden
State/province [212] 0 0
Uppsala
Country [213] 0 0
Switzerland
State/province [213] 0 0
Basel
Country [214] 0 0
Switzerland
State/province [214] 0 0
Bern
Country [215] 0 0
Switzerland
State/province [215] 0 0
Fribourg
Country [216] 0 0
Switzerland
State/province [216] 0 0
Geneva
Country [217] 0 0
Switzerland
State/province [217] 0 0
Lausanne
Country [218] 0 0
Switzerland
State/province [218] 0 0
Lugano
Country [219] 0 0
Switzerland
State/province [219] 0 0
Zürich
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Birmingham
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Blackpool
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Bristol
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Leeds
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Leicester
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Liverpool
Country [226] 0 0
United Kingdom
State/province [226] 0 0
London
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Manchester
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Middlesbrough
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Northampton
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Nottingham
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Sheffield
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00271180
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Product Performance Report Study Leader
Address 0 0
Medtronic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medtronic CRM Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00271180