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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01524276




Registration number
NCT01524276
Ethics application status
Date submitted
30/01/2012
Date registered
1/02/2012
Date last updated
14/06/2019

Titles & IDs
Public title
Product Surveillance Registry
Scientific title
Medtronic Product Surveillance Registry
Secondary ID [1] 0 0
PSR
Universal Trial Number (UTN)
Trial acronym
PSR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Rhythm Disorders 0 0
Urological Disorders 0 0
Neurological Disorders 0 0
Cardiovascular Disorders 0 0
Digestive Disorders 0 0
Intracranial Aneurysm 0 0
Mechanical Circulatory Support 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

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
Safety and Effectiveness of Market Released products
Timepoint [1] 0 0
Every 6-12 months (Therapy-dependent)

Eligibility
Key inclusion criteria
- Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements

- Patient has or is intended to receive or be treated with an eligible Medtronic product

- Patient within enrollment window relative to therapy initiation or meets criteria for
retrospective enrollment
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient who is, or will be, inaccessible for follow-up

- Patient with exclusion criteria required by local law

- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Southport
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 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
Delaware
Country [9] 0 0
United States of America
State/province [9] 0 0
District of Columbia
Country [10] 0 0
United States of America
State/province [10] 0 0
Florida
Country [11] 0 0
United States of America
State/province [11] 0 0
Georgia
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Missouri
Country [23] 0 0
United States of America
State/province [23] 0 0
Montana
Country [24] 0 0
United States of America
State/province [24] 0 0
Nebraska
Country [25] 0 0
United States of America
State/province [25] 0 0
Nevada
Country [26] 0 0
United States of America
State/province [26] 0 0
New Jersey
Country [27] 0 0
United States of America
State/province [27] 0 0
New Mexico
Country [28] 0 0
United States of America
State/province [28] 0 0
New York
Country [29] 0 0
United States of America
State/province [29] 0 0
North Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Ohio
Country [31] 0 0
United States of America
State/province [31] 0 0
Oklahoma
Country [32] 0 0
United States of America
State/province [32] 0 0
Oregon
Country [33] 0 0
United States of America
State/province [33] 0 0
Pennsylvania
Country [34] 0 0
United States of America
State/province [34] 0 0
South Carolina
Country [35] 0 0
United States of America
State/province [35] 0 0
South Dakota
Country [36] 0 0
United States of America
State/province [36] 0 0
Tennessee
Country [37] 0 0
United States of America
State/province [37] 0 0
Texas
Country [38] 0 0
United States of America
State/province [38] 0 0
Utah
Country [39] 0 0
United States of America
State/province [39] 0 0
Vermont
Country [40] 0 0
United States of America
State/province [40] 0 0
Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Washington
Country [42] 0 0
United States of America
State/province [42] 0 0
Wisconsin
Country [43] 0 0
Argentina
State/province [43] 0 0
Buenos Aires
Country [44] 0 0
Belgium
State/province [44] 0 0
Brugge
Country [45] 0 0
Belgium
State/province [45] 0 0
Brussel
Country [46] 0 0
Belgium
State/province [46] 0 0
Edegem
Country [47] 0 0
Belgium
State/province [47] 0 0
Leuven
Country [48] 0 0
Belgium
State/province [48] 0 0
Liege
Country [49] 0 0
Belgium
State/province [49] 0 0
Sint-Niklaas
Country [50] 0 0
Belgium
State/province [50] 0 0
Wilrijk
Country [51] 0 0
Belgium
State/province [51] 0 0
Yvoir
Country [52] 0 0
Canada
State/province [52] 0 0
Alberta
Country [53] 0 0
Canada
State/province [53] 0 0
Ontario
Country [54] 0 0
Canada
State/province [54] 0 0
Quebec
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec City
Country [56] 0 0
Canada
State/province [56] 0 0
Toronto
Country [57] 0 0
China
State/province [57] 0 0
Hong Kong
Country [58] 0 0
Colombia
State/province [58] 0 0
Bogota
Country [59] 0 0
Colombia
State/province [59] 0 0
Medellin
Country [60] 0 0
Colombia
State/province [60] 0 0
Pereira
Country [61] 0 0
Colombia
State/province [61] 0 0
Rionegro
Country [62] 0 0
Czechia
State/province [62] 0 0
Praha
Country [63] 0 0
Denmark
State/province [63] 0 0
Copenhagen
Country [64] 0 0
Denmark
State/province [64] 0 0
Hellerup
Country [65] 0 0
Denmark
State/province [65] 0 0
Hillerød
Country [66] 0 0
Denmark
State/province [66] 0 0
Odense
Country [67] 0 0
Denmark
State/province [67] 0 0
Århus N
Country [68] 0 0
Finland
State/province [68] 0 0
Turku
Country [69] 0 0
France
State/province [69] 0 0
Bayonne
Country [70] 0 0
France
State/province [70] 0 0
Besançon
Country [71] 0 0
France
State/province [71] 0 0
Bordeaux
Country [72] 0 0
France
State/province [72] 0 0
Brest Cedex
Country [73] 0 0
France
State/province [73] 0 0
Chambray
Country [74] 0 0
France
State/province [74] 0 0
Clermont Ferrand
Country [75] 0 0
France
State/province [75] 0 0
Créteil
Country [76] 0 0
France
State/province [76] 0 0
La Rochelle
Country [77] 0 0
France
State/province [77] 0 0
La Tronche
Country [78] 0 0
France
State/province [78] 0 0
Lille
Country [79] 0 0
France
State/province [79] 0 0
Limoges
Country [80] 0 0
France
State/province [80] 0 0
Lyon
Country [81] 0 0
France
State/province [81] 0 0
Marseille
Country [82] 0 0
France
State/province [82] 0 0
Montpellier
Country [83] 0 0
France
State/province [83] 0 0
Nantes
Country [84] 0 0
France
State/province [84] 0 0
Neuilly
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Pessac
Country [87] 0 0
France
State/province [87] 0 0
Pringy
Country [88] 0 0
France
State/province [88] 0 0
Reims
Country [89] 0 0
France
State/province [89] 0 0
Rennes
Country [90] 0 0
France
State/province [90] 0 0
Rouen
Country [91] 0 0
France
State/province [91] 0 0
Saint Priest
Country [92] 0 0
France
State/province [92] 0 0
Saint-Étienne
Country [93] 0 0
France
State/province [93] 0 0
Strasbourg
Country [94] 0 0
France
State/province [94] 0 0
Toulouse
Country [95] 0 0
France
State/province [95] 0 0
VandÅ“uvre-lès-Nancy
Country [96] 0 0
France
State/province [96] 0 0
Villeurbanne
Country [97] 0 0
Germany
State/province [97] 0 0
Aachen
Country [98] 0 0
Germany
State/province [98] 0 0
Augsburg
Country [99] 0 0
Germany
State/province [99] 0 0
Berlin
Country [100] 0 0
Germany
State/province [100] 0 0
Dresden
Country [101] 0 0
Germany
State/province [101] 0 0
Düsseldorf
Country [102] 0 0
Germany
State/province [102] 0 0
Erfurt
Country [103] 0 0
Germany
State/province [103] 0 0
Erlangen
Country [104] 0 0
Germany
State/province [104] 0 0
Essen
Country [105] 0 0
Germany
State/province [105] 0 0
Frankfurt am Main
Country [106] 0 0
Germany
State/province [106] 0 0
Hamburg
Country [107] 0 0
Germany
State/province [107] 0 0
Hannover
Country [108] 0 0
Germany
State/province [108] 0 0
Heidelberg
Country [109] 0 0
Germany
State/province [109] 0 0
Homburg
Country [110] 0 0
Germany
State/province [110] 0 0
Jena
Country [111] 0 0
Germany
State/province [111] 0 0
Koln
Country [112] 0 0
Germany
State/province [112] 0 0
Munster
Country [113] 0 0
Germany
State/province [113] 0 0
Tubingen
Country [114] 0 0
Germany
State/province [114] 0 0
Ulm
Country [115] 0 0
Germany
State/province [115] 0 0
Villingen-Schwenningen
Country [116] 0 0
Greece
State/province [116] 0 0
Athens
Country [117] 0 0
Greece
State/province [117] 0 0
Maroúsi
Country [118] 0 0
Hungary
State/province [118] 0 0
Budapest
Country [119] 0 0
Iceland
State/province [119] 0 0
Reykjavik
Country [120] 0 0
Israel
State/province [120] 0 0
Ashqelon
Country [121] 0 0
Israel
State/province [121] 0 0
Jerusalem
Country [122] 0 0
Israel
State/province [122] 0 0
Ramat Gan
Country [123] 0 0
Israel
State/province [123] 0 0
Tel Aviv
Country [124] 0 0
Italy
State/province [124] 0 0
Bari
Country [125] 0 0
Italy
State/province [125] 0 0
Bologna
Country [126] 0 0
Italy
State/province [126] 0 0
Brescia
Country [127] 0 0
Italy
State/province [127] 0 0
Cotignola
Country [128] 0 0
Italy
State/province [128] 0 0
Firenze
Country [129] 0 0
Italy
State/province [129] 0 0
Milano
Country [130] 0 0
Italy
State/province [130] 0 0
Pavia
Country [131] 0 0
Italy
State/province [131] 0 0
Pisa
Country [132] 0 0
Italy
State/province [132] 0 0
Reggio Emilia
Country [133] 0 0
Japan
State/province [133] 0 0
Mitaka
Country [134] 0 0
Japan
State/province [134] 0 0
Shinagawa-Ku
Country [135] 0 0
Japan
State/province [135] 0 0
Suita
Country [136] 0 0
Japan
State/province [136] 0 0
Yokohama
Country [137] 0 0
Jordan
State/province [137] 0 0
Amman
Country [138] 0 0
Kuwait
State/province [138] 0 0
Hadiya
Country [139] 0 0
Malaysia
State/province [139] 0 0
Kuala Lumpur
Country [140] 0 0
Mexico
State/province [140] 0 0
Ciudad de mexico
Country [141] 0 0
Netherlands
State/province [141] 0 0
Amsterdam
Country [142] 0 0
Netherlands
State/province [142] 0 0
Breda
Country [143] 0 0
Netherlands
State/province [143] 0 0
Den Haag
Country [144] 0 0
Netherlands
State/province [144] 0 0
Eindhoven
Country [145] 0 0
Netherlands
State/province [145] 0 0
Enschede
Country [146] 0 0
Netherlands
State/province [146] 0 0
Groningen
Country [147] 0 0
Netherlands
State/province [147] 0 0
Leiden
Country [148] 0 0
Netherlands
State/province [148] 0 0
Maastricht
Country [149] 0 0
Netherlands
State/province [149] 0 0
Nieuwegein
Country [150] 0 0
Netherlands
State/province [150] 0 0
Nijmegen
Country [151] 0 0
Netherlands
State/province [151] 0 0
Rotterdam
Country [152] 0 0
New Zealand
State/province [152] 0 0
Christchurch
Country [153] 0 0
Norway
State/province [153] 0 0
Bergen
Country [154] 0 0
Norway
State/province [154] 0 0
Trondheim
Country [155] 0 0
Poland
State/province [155] 0 0
Poznan
Country [156] 0 0
Poland
State/province [156] 0 0
Zabrze
Country [157] 0 0
Portugal
State/province [157] 0 0
Lisboa
Country [158] 0 0
Puerto Rico
State/province [158] 0 0
Aibonito
Country [159] 0 0
Puerto Rico
State/province [159] 0 0
Rio Piedras
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Novosibirsk
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Saint Petersburg
Country [162] 0 0
Saudi Arabia
State/province [162] 0 0
Jeddah
Country [163] 0 0
Saudi Arabia
State/province [163] 0 0
Riyadh
Country [164] 0 0
Serbia
State/province [164] 0 0
Belgrade
Country [165] 0 0
Slovakia
State/province [165] 0 0
Bratislava
Country [166] 0 0
Slovenia
State/province [166] 0 0
Ljubljana
Country [167] 0 0
South Africa
State/province [167] 0 0
Soweto
Country [168] 0 0
Spain
State/province [168] 0 0
A Coruña
Country [169] 0 0
Spain
State/province [169] 0 0
Barcelona
Country [170] 0 0
Spain
State/province [170] 0 0
Madrid
Country [171] 0 0
Spain
State/province [171] 0 0
Oviedo
Country [172] 0 0
Spain
State/province [172] 0 0
San Sebastián
Country [173] 0 0
Spain
State/province [173] 0 0
Santiago
Country [174] 0 0
Spain
State/province [174] 0 0
Toledo
Country [175] 0 0
Spain
State/province [175] 0 0
Vitoria
Country [176] 0 0
Sweden
State/province [176] 0 0
Skövde
Country [177] 0 0
Sweden
State/province [177] 0 0
Uppsala
Country [178] 0 0
Switzerland
State/province [178] 0 0
Basel
Country [179] 0 0
Switzerland
State/province [179] 0 0
Bern
Country [180] 0 0
Switzerland
State/province [180] 0 0
Fribourg
Country [181] 0 0
Switzerland
State/province [181] 0 0
Geneve
Country [182] 0 0
Switzerland
State/province [182] 0 0
Lausanne
Country [183] 0 0
Switzerland
State/province [183] 0 0
Lugano
Country [184] 0 0
Switzerland
State/province [184] 0 0
Morges
Country [185] 0 0
Switzerland
State/province [185] 0 0
Zürich
Country [186] 0 0
United Arab Emirates
State/province [186] 0 0
Abu Dhabi
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Aberdeen
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Birmingham
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Bristol
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Chelmsford
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Glasgow
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Leeds
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Leicester
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Liverpool
Country [195] 0 0
United Kingdom
State/province [195] 0 0
London
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Manchester
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Middlesbrough
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Romford
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Southampton
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Stoke-on-Trent

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the Registry is to provide continuing evaluation and periodic reporting of
safety and effectiveness of Medtronic market-released products. The Registry data is intended
to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,
payers, and industry by streamlining the clinical surveillance process and facilitating
leading edge performance assessment via the least burdensome approach.
Trial website
https://clinicaltrials.gov/show/NCT01524276
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medtronic Product Surveillance Registry
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
rs.productsurveillanceregistry@medtronic.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01524276