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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
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United States of America
State/province [2] 0 0
Alaska
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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United States of America
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Missouri
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United States of America
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Nebraska
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New Hampshire
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United States of America
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New Mexico
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West Virginia
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Montpellier Cedex 5
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France
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Nantes
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France
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Neuilly-sur-Seine
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Ollioules
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Pringy
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Rennes
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Strasbourg
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France
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Villeurbanne
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Germany
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Aachen
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Bad Oeynhausen
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Bremen
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Düsseldorf
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Essen
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Frankfurt am main
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Hagen
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Jena
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Germany
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Leipzig
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Lübeck
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Germany
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Munster
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Germany
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München
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Germany
State/province [122] 0 0
Ulm
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Germany
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Greece
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Athens
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Maroúsi
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Greece
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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India
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Israel
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Acquaviva Delle Fonti
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Ancona
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Bassano Del Grappa
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Bologna
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Brescia
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Caserta
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Castrovillari
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Chieri
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State/province [145] 0 0
Lecce
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Milano
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Monza
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Palermo
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Italy
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Pavia
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Italy
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Roma
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State/province [151] 0 0
Rome
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Taranto
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Udine
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Japan
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Osaka
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Japan
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Japan
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Tachikawa
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Japan
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Tokyo
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Japan
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Oslo
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Trondheim
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Poznan
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Poland
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Creixomil
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Lisboa
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Porto
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Puerto Rico
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Belgrade
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Spain
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Girona
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Spain
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Spain
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L'Hospitalet De Llobregat
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Palma De Mallorca
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Spain
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Salamanca
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Spain
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Santa Cruz De Tenerife
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Spain
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Santiago De Compostela
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Spain
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Toledo
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Spain
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Valencia
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Spain
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Valladolid
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Sweden
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Sweden
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Lund
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Sweden
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Skövde
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Switzerland
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Switzerland
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Switzerland
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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