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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
29/08/2025
Titles & IDs
Public title
Product Surveillance Registry
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Scientific title
Medtronic Product Surveillance Registry
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Secondary ID [1]
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0
PSR
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Universal Trial Number (UTN)
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Trial acronym
PSR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Rhythm Disorders
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Urological Disorders
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Neurological Disorders
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Cardiovascular Disorders
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Digestive Disorders
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0
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Intracranial Aneurysm
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0
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Mechanical Circulatory Support
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0
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Respiratory Therapy
0
0
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Aortic, Peripheral Vascular and Venous Disorders
0
0
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Minimally Invasive Surgical Procedures
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0
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Diagnostic Techniques and Procedures
0
0
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Surgical Procedures, Operative
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0
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Renal Insufficiency
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Neurovascular
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Coronary Artery Disease
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Ear, Nose and Throat Disorder
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0
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Condition category
Condition code
Renal and Urogenital
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0
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0
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Other renal and urogenital disorders
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Cardiovascular
0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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0
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Other neurological disorders
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Renal and Urogenital
0
0
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0
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Kidney disease
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Cardiovascular
0
0
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0
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Coronary heart disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Effectiveness of Market Released products
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Assessment method [1]
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Timepoint [1]
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Every 6-12 months (Therapy-dependent)
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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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2040
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Actual
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Sample size
Target
100000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Westmead
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Recruitment hospital [2]
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- Chermside
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Recruitment hospital [3]
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- Murdoch
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Recruitment hospital [4]
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- Southport
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment postcode(s) [2]
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- Chermside
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Recruitment postcode(s) [3]
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- Murdoch
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Recruitment postcode(s) [4]
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- Southport
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Recruitment outside Australia
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Alabama
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Arizona
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Colorado
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Connecticut
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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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New York
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North Carolina
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Ohio
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Oregon
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Texas
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Utah
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Vermont
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Virginia
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Washington
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Wisconsin
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Argentina
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Austria
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Innsbruck
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Austria
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Linz
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Belgium
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Belgium
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Aalst
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Belgium
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Bruges
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Ghent
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Roeselare
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Belgium
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Sint-Niklaas
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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
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Ontario
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Canada
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Quebec
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Canada
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Québec
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Canada
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Toronto
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China
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Sichuan
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China
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Beijing
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China
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Chengdu
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China
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Dalian
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Country [64]
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China
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Guangzhou
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China
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Hangzhou
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China
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Harbin
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China
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Kunming
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China
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Nanchang
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China
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Shanghai
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Country [70]
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China
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Suzhou
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Colombia
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State/province [71]
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MedellÃn
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Country [72]
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Colombia
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State/province [72]
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Pereira
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Country [73]
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Colombia
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State/province [73]
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Rionegro
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Country [74]
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Czechia
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Prague
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Denmark
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Copenhagen
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Denmark
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Hellerup
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Denmark
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Hillerød
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Denmark
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Odense
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Finland
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Helsinki
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Finland
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Tampere
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France
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Avignon
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France
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Bordeaux
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France
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Boulogne-Billancourt
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France
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Brest
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France
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Caen
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France
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Chambray
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France
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Clermont-Ferrand
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France
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Créteil
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France
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Dijon
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France
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La Rochelle
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France
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State/province [91]
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La Tronche
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France
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Lille
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France
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Marseille
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France
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Montpellier
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France
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Nantes
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France
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Ollioules
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France
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Paris
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France
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Pessac
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France
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Pringy
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France
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Rennes
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France
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Saint-Priest-en-Jarez
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France
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Strasbourg
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Toulouse
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France
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Villeurbanne
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Germany
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Aachen
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Germany
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Arnsberg
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Germany
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Bad Oeynhausen
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Germany
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Berlin
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Bochum
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Bremen
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Düsseldorf
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Germany
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Freiburg im Breisgau
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Germany
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Hagen
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Germany
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Halle
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Germany
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Hamburg
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Heidelberg
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Jena
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Lübeck
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Ulm
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India
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India
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Israel
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Ashkelon
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Israel
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Italy
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Acquaviva delle Fonti
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Italy
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Italy
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Caserta
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Italy
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Roma
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Udine
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Portugal
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Incheon
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Seoul
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Suwon
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A Coruña
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Granada
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L'Hospitalet de Llobregat
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Taichung
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Blackpool
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Bristol
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Chelmsford
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Glasgow
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Harrow
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Leeds
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Leicester
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London
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Manchester
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Northampton
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Sheffield
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01524276
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Trial related presentations / publications
Goya M, Park SJ, Ando K, Holbrook R, Iskandar R, Jacobsen L, Mozingo JD, Joung B; SPARK Registry Investigators. Safety and efficacy of an intrinsic antitachycardia pacing algorithm in patients from Japan and South Korea: results from a cardiac device registry in the Asia Pacific region. J Med Econ. 2025 Dec;28(1):1307-1318. doi: 10.1080/13696998.2025.2543213. Epub 2025 Aug 13. Patel D, Rao A, Friedman PA, Deshmukh AJ, Lande J, Murphy JA, Brown ML, Lexcen DR, Wilkoff BL. New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation. J Cardiovasc Electrophysiol. 2023 Feb;34(2):438-444. doi: 10.1111/jce.15790. Epub 2022 Dec 30. 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.
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Medtronic Product Surveillance Registry
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01524276
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