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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01524276
Ethics application status
Date submitted
30/01/2012
Date registered
1/02/2012
Date last updated
21/10/2024

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
Respiratory Therapy 0 0
Aortic, Peripheral Vascular and Venous Disorders 0 0
Minimally Invasive Surgical Procedures 0 0
Diagnostic Techniques and Procedures 0 0
Surgical Procedures, Operative 0 0
Renal Insufficiency 0 0
Neurovascular 0 0
Coronary Artery Disease 0 0
Ear, Nose and Throat Disorder 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
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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
Sex
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
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2030
Actual
Sample size
Target
100000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Westmead
Recruitment hospital [2] 0 0
- Chermside
Recruitment hospital [3] 0 0
- Murdoch
Recruitment hospital [4] 0 0
- Southport
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Chermside
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
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
Country [15] 0 0
United States of America
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Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
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United States of America
State/province [17] 0 0
Maryland
Country [18] 0 0
United States of America
State/province [18] 0 0
Massachusetts
Country [19] 0 0
United States of America
State/province [19] 0 0
Michigan
Country [20] 0 0
United States of America
State/province [20] 0 0
Minnesota
Country [21] 0 0
United States of America
State/province [21] 0 0
Mississippi
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
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
New Hampshire
Country [25] 0 0
United States of America
State/province [25] 0 0
New Jersey
Country [26] 0 0
United States of America
State/province [26] 0 0
New Mexico
Country [27] 0 0
United States of America
State/province [27] 0 0
New York
Country [28] 0 0
United States of America
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North Carolina
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United States of America
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Ohio
Country [30] 0 0
United States of America
State/province [30] 0 0
Oregon
Country [31] 0 0
United States of America
State/province [31] 0 0
Pennsylvania
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
South Dakota
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United States of America
State/province [34] 0 0
Tennessee
Country [35] 0 0
United States of America
State/province [35] 0 0
Texas
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United States of America
State/province [36] 0 0
Utah
Country [37] 0 0
United States of America
State/province [37] 0 0
Vermont
Country [38] 0 0
United States of America
State/province [38] 0 0
Virginia
Country [39] 0 0
United States of America
State/province [39] 0 0
Washington
Country [40] 0 0
United States of America
State/province [40] 0 0
West Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Wisconsin
Country [42] 0 0
Argentina
State/province [42] 0 0
Buenos Aires
Country [43] 0 0
Austria
State/province [43] 0 0
Innsbruck
Country [44] 0 0
Austria
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Linz
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Belgium
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Aalst
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Belgium
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Brugge
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Belgium
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Brussel
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Roeselare
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
State/province [55] 0 0
Ontario
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Canada
State/province [56] 0 0
Quebec
Country [57] 0 0
Canada
State/province [57] 0 0
Quebec City
Country [58] 0 0
Canada
State/province [58] 0 0
Toronto
Country [59] 0 0
China
State/province [59] 0 0
Sichuan
Country [60] 0 0
China
State/province [60] 0 0
Beijing
Country [61] 0 0
China
State/province [61] 0 0
Dalian
Country [62] 0 0
China
State/province [62] 0 0
Guangzhou
Country [63] 0 0
China
State/province [63] 0 0
Hangzhou
Country [64] 0 0
China
State/province [64] 0 0
Harbin
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China
State/province [65] 0 0
Kunming
Country [66] 0 0
China
State/province [66] 0 0
Nanchang
Country [67] 0 0
China
State/province [67] 0 0
Shanghai
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China
State/province [68] 0 0
Suzhou
Country [69] 0 0
China
State/province [69] 0 0
Taiyuan
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China
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Tianjin
Country [71] 0 0
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Cartagena
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Medellin
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Pereira
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Rionegro
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Praha
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State/province [76] 0 0
Hellerup
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Denmark
State/province [77] 0 0
Hillerød
Country [78] 0 0
Denmark
State/province [78] 0 0
Kobenhavn
Country [79] 0 0
Denmark
State/province [79] 0 0
Odense
Country [80] 0 0
Finland
State/province [80] 0 0
Helsinki
Country [81] 0 0
Finland
State/province [81] 0 0
Tampere
Country [82] 0 0
France
State/province [82] 0 0
Avignon
Country [83] 0 0
France
State/province [83] 0 0
Bordeaux
Country [84] 0 0
France
State/province [84] 0 0
Boulogne-Billancourt
Country [85] 0 0
France
State/province [85] 0 0
Brest Cedex
Country [86] 0 0
France
State/province [86] 0 0
Caen
Country [87] 0 0
France
State/province [87] 0 0
Chambray
Country [88] 0 0
France
State/province [88] 0 0
Clermont Ferrand
Country [89] 0 0
France
State/province [89] 0 0
Créteil
Country [90] 0 0
France
State/province [90] 0 0
Dijon
Country [91] 0 0
France
State/province [91] 0 0
La Rochelle
Country [92] 0 0
France
State/province [92] 0 0
La Tronche
Country [93] 0 0
France
State/province [93] 0 0
Lille Cedex
Country [94] 0 0
France
State/province [94] 0 0
Marseille Cedex 5
Country [95] 0 0
France
State/province [95] 0 0
Montpellier Cedex 5
Country [96] 0 0
France
State/province [96] 0 0
Nantes
Country [97] 0 0
France
State/province [97] 0 0
Neuilly-sur-Seine
Country [98] 0 0
France
State/province [98] 0 0
Ollioules
Country [99] 0 0
France
State/province [99] 0 0
Paris
Country [100] 0 0
France
State/province [100] 0 0
Pringy
Country [101] 0 0
France
State/province [101] 0 0
Rennes
Country [102] 0 0
France
State/province [102] 0 0
Saint-Priest-en-Jarez
Country [103] 0 0
France
State/province [103] 0 0
Strasbourg
Country [104] 0 0
France
State/province [104] 0 0
Villeurbanne
Country [105] 0 0
Germany
State/province [105] 0 0
Aachen
Country [106] 0 0
Germany
State/province [106] 0 0
Bad Oeynhausen
Country [107] 0 0
Germany
State/province [107] 0 0
Bremen
Country [108] 0 0
Germany
State/province [108] 0 0
Düsseldorf
Country [109] 0 0
Germany
State/province [109] 0 0
Essen
Country [110] 0 0
Germany
State/province [110] 0 0
Frankfurt am main
Country [111] 0 0
Germany
State/province [111] 0 0
Freiburg
Country [112] 0 0
Germany
State/province [112] 0 0
Hagen
Country [113] 0 0
Germany
State/province [113] 0 0
Hamburg
Country [114] 0 0
Germany
State/province [114] 0 0
Hannover
Country [115] 0 0
Germany
State/province [115] 0 0
Jena
Country [116] 0 0
Germany
State/province [116] 0 0
Karlsruhe
Country [117] 0 0
Germany
State/province [117] 0 0
Köln
Country [118] 0 0
Germany
State/province [118] 0 0
Leipzig
Country [119] 0 0
Germany
State/province [119] 0 0
Lübeck
Country [120] 0 0
Germany
State/province [120] 0 0
Munster
Country [121] 0 0
Germany
State/province [121] 0 0
München
Country [122] 0 0
Germany
State/province [122] 0 0
Ulm
Country [123] 0 0
Germany
State/province [123] 0 0
Wiesbaden
Country [124] 0 0
Greece
State/province [124] 0 0
Athens
Country [125] 0 0
Greece
State/province [125] 0 0
Maroúsi
Country [126] 0 0
Greece
State/province [126] 0 0
Thessaloníki
Country [127] 0 0
Hong Kong
State/province [127] 0 0
Hong Kong
Country [128] 0 0
Hungary
State/province [128] 0 0
Budapest
Country [129] 0 0
India
State/province [129] 0 0
Telangana
Country [130] 0 0
India
State/province [130] 0 0
Chennai
Country [131] 0 0
India
State/province [131] 0 0
New Delhi
Country [132] 0 0
Ireland
State/province [132] 0 0
Galway
Country [133] 0 0
Israel
State/province [133] 0 0
Be'er Sheva
Country [134] 0 0
Israel
State/province [134] 0 0
Jerusalem
Country [135] 0 0
Israel
State/province [135] 0 0
Ramat Gan
Country [136] 0 0
Italy
State/province [136] 0 0
Acquaviva Delle Fonti
Country [137] 0 0
Italy
State/province [137] 0 0
Ancona
Country [138] 0 0
Italy
State/province [138] 0 0
Bari
Country [139] 0 0
Italy
State/province [139] 0 0
Bassano Del Grappa
Country [140] 0 0
Italy
State/province [140] 0 0
Bologna
Country [141] 0 0
Italy
State/province [141] 0 0
Brescia
Country [142] 0 0
Italy
State/province [142] 0 0
Caserta
Country [143] 0 0
Italy
State/province [143] 0 0
Castrovillari
Country [144] 0 0
Italy
State/province [144] 0 0
Chieri
Country [145] 0 0
Italy
State/province [145] 0 0
Lecce
Country [146] 0 0
Italy
State/province [146] 0 0
Milano
Country [147] 0 0
Italy
State/province [147] 0 0
Monza
Country [148] 0 0
Italy
State/province [148] 0 0
Palermo
Country [149] 0 0
Italy
State/province [149] 0 0
Pavia
Country [150] 0 0
Italy
State/province [150] 0 0
Roma
Country [151] 0 0
Italy
State/province [151] 0 0
Rome
Country [152] 0 0
Italy
State/province [152] 0 0
Taranto
Country [153] 0 0
Italy
State/province [153] 0 0
Udine
Country [154] 0 0
Italy
State/province [154] 0 0
Vimercate
Country [155] 0 0
Japan
State/province [155] 0 0
Osaka
Country [156] 0 0
Japan
State/province [156] 0 0
Saitama
Country [157] 0 0
Japan
State/province [157] 0 0
Tachikawa
Country [158] 0 0
Japan
State/province [158] 0 0
Tokyo
Country [159] 0 0
Japan
State/province [159] 0 0
Tottori
Country [160] 0 0
Japan
State/province [160] 0 0
Chiba
Country [161] 0 0
Japan
State/province [161] 0 0
Fukuoka
Country [162] 0 0
Japan
State/province [162] 0 0
Gifu
Country [163] 0 0
Japan
State/province [163] 0 0
Hirosaki
Country [164] 0 0
Japan
State/province [164] 0 0
Hiroshima City
Country [165] 0 0
Japan
State/province [165] 0 0
Hiroshima
Country [166] 0 0
Japan
State/province [166] 0 0
Kagoshima
Country [167] 0 0
Japan
State/province [167] 0 0
Kamakura
Country [168] 0 0
Japan
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Kawasaki
Country [169] 0 0
Japan
State/province [169] 0 0
Kitakyushu
Country [170] 0 0
Japan
State/province [170] 0 0
Kofu
Country [171] 0 0
Japan
State/province [171] 0 0
Kumamoto
Country [172] 0 0
Japan
State/province [172] 0 0
Kyoto
Country [173] 0 0
Japan
State/province [173] 0 0
Mitaka
Country [174] 0 0
Japan
State/province [174] 0 0
Nagoya
Country [175] 0 0
Japan
State/province [175] 0 0
Niigata
Country [176] 0 0
Japan
State/province [176] 0 0
Okayama
Country [177] 0 0
Japan
State/province [177] 0 0
Sapporo
Country [178] 0 0
Japan
State/province [178] 0 0
Shinagawa-Ku
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Japan
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Shizuoka
Country [180] 0 0
Japan
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Japan
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Japan
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Japan
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Korea, Republic of
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Korea, Republic of
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Daegu
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Korea, Republic of
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Korea, Republic of
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Gangneung
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
State/province [195] 0 0
Jeonju
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Korea, Republic of
State/province [196] 0 0
Seongnam-si
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Korea, Republic of
State/province [197] 0 0
Seoul
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Korea, Republic of
State/province [198] 0 0
Suwon-si
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Kuwait
State/province [199] 0 0
Kuwait
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Malaysia
State/province [200] 0 0
Kuala Lumpur
Country [201] 0 0
Mexico
State/province [201] 0 0
Ciudad de mexico
Country [202] 0 0
Netherlands
State/province [202] 0 0
Eindhoven
Country [203] 0 0
Netherlands
State/province [203] 0 0
Enschede
Country [204] 0 0
Netherlands
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Groningen
Country [205] 0 0
Netherlands
State/province [205] 0 0
Heerlen
Country [206] 0 0
Netherlands
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Hengelo
Country [207] 0 0
Netherlands
State/province [207] 0 0
Leiden
Country [208] 0 0
Netherlands
State/province [208] 0 0
Maastricht
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Netherlands
State/province [209] 0 0
Nieuwegein
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Netherlands
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Rotterdam
Country [211] 0 0
New Zealand
State/province [211] 0 0
Christchurch
Country [212] 0 0
Norway
State/province [212] 0 0
Bergen
Country [213] 0 0
Norway
State/province [213] 0 0
Oslo
Country [214] 0 0
Norway
State/province [214] 0 0
Trondheim
Country [215] 0 0
Poland
State/province [215] 0 0
Poznan
Country [216] 0 0
Poland
State/province [216] 0 0
Warszawa
Country [217] 0 0
Poland
State/province [217] 0 0
Zabrze
Country [218] 0 0
Portugal
State/province [218] 0 0
Creixomil
Country [219] 0 0
Portugal
State/province [219] 0 0
Lisboa
Country [220] 0 0
Portugal
State/province [220] 0 0
Porto
Country [221] 0 0
Portugal
State/province [221] 0 0
Santarém
Country [222] 0 0
Puerto Rico
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Aibonito
Country [223] 0 0
Puerto Rico
State/province [223] 0 0
Rio Piedras
Country [224] 0 0
Saudi Arabia
State/province [224] 0 0
Jeddah
Country [225] 0 0
Serbia
State/province [225] 0 0
Belgrade
Country [226] 0 0
Slovakia
State/province [226] 0 0
Bratislava
Country [227] 0 0
Spain
State/province [227] 0 0
A Coruña
Country [228] 0 0
Spain
State/province [228] 0 0
Barcelona
Country [229] 0 0
Spain
State/province [229] 0 0
Córdoba
Country [230] 0 0
Spain
State/province [230] 0 0
Girona
Country [231] 0 0
Spain
State/province [231] 0 0
Granada
Country [232] 0 0
Spain
State/province [232] 0 0
L'Hospitalet De Llobregat
Country [233] 0 0
Spain
State/province [233] 0 0
Madrid
Country [234] 0 0
Spain
State/province [234] 0 0
Málaga
Country [235] 0 0
Spain
State/province [235] 0 0
Palma De Mallorca
Country [236] 0 0
Spain
State/province [236] 0 0
Salamanca
Country [237] 0 0
Spain
State/province [237] 0 0
Santa Cruz De Tenerife
Country [238] 0 0
Spain
State/province [238] 0 0
Santiago De Compostela
Country [239] 0 0
Spain
State/province [239] 0 0
Toledo
Country [240] 0 0
Spain
State/province [240] 0 0
Valencia
Country [241] 0 0
Spain
State/province [241] 0 0
Valladolid
Country [242] 0 0
Sweden
State/province [242] 0 0
Göteborg
Country [243] 0 0
Sweden
State/province [243] 0 0
Lund
Country [244] 0 0
Sweden
State/province [244] 0 0
Skövde
Country [245] 0 0
Switzerland
State/province [245] 0 0
Basel
Country [246] 0 0
Switzerland
State/province [246] 0 0
Bern
Country [247] 0 0
Switzerland
State/province [247] 0 0
Fribourg
Country [248] 0 0
Switzerland
State/province [248] 0 0
Geneve
Country [249] 0 0
Switzerland
State/province [249] 0 0
Lausanne
Country [250] 0 0
Switzerland
State/province [250] 0 0
Lugano
Country [251] 0 0
Switzerland
State/province [251] 0 0
Morges
Country [252] 0 0
Switzerland
State/province [252] 0 0
Zürich
Country [253] 0 0
United Kingdom
State/province [253] 0 0
Barnstaple
Country [254] 0 0
United Kingdom
State/province [254] 0 0
Birmingham
Country [255] 0 0
United Kingdom
State/province [255] 0 0
Blackpool
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Bristol
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Leeds
Country [258] 0 0
United Kingdom
State/province [258] 0 0
Leicester
Country [259] 0 0
United Kingdom
State/province [259] 0 0
Liverpool
Country [260] 0 0
United Kingdom
State/province [260] 0 0
London
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Manchester
Country [262] 0 0
United Kingdom
State/province [262] 0 0
Middlesbrough
Country [263] 0 0
United Kingdom
State/province [263] 0 0
Newcastle Upon Tyne
Country [264] 0 0
United Kingdom
State/province [264] 0 0
Northampton
Country [265] 0 0
United Kingdom
State/province [265] 0 0
Nottingham
Country [266] 0 0
United Kingdom
State/province [266] 0 0
Sheffield

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/study/NCT01524276
Trial related presentations / publications
Qin D, Filippaios A, Murphy J, Berg M, Lampert R, Schloss EJ, Noone M, Mela T. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4.
Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.
Singh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28.
Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425.
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
[email protected]
Contact person for scientific queries



Summary Results

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