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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00637754




Registration number
NCT00637754
Ethics application status
Date submitted
11/03/2008
Date registered
18/03/2008
Date last updated
11/06/2015

Titles & IDs
Public title
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators
Scientific title
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry
Secondary ID [1] 0 0
0608001730
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrhythmias 0 0
Condition category
Condition code
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
Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
Timepoint [1] 0 0
four years
Secondary outcome [1] 0 0
System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination
Timepoint [1] 0 0
four years.

Eligibility
Key inclusion criteria
- individuals between the ages of 10 and 60

- has a defibrillator

- plays a competitive/organized sport more vigorous than golf or bowling or participates
in a dangerous sport
Minimum age
10 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- children under 10 years (as they engage in primarily recreational sports)

- individuals over the age of 60 years (maintain a homogenous population)

- inability to give informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital, Mebourne LTD - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
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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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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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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Iowa
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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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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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
Country [18] 0 0
United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Utah
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United States of America
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Washington
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United States of America
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Wisconsin
Country [23] 0 0
Belgium
State/province [23] 0 0
Aalst
Country [24] 0 0
Belgium
State/province [24] 0 0
Arlon
Country [25] 0 0
Belgium
State/province [25] 0 0
Edegem
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
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Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Praha 4
Country [31] 0 0
France
State/province [31] 0 0
Rennes
Country [32] 0 0
France
State/province [32] 0 0
Toulouse
Country [33] 0 0
Germany
State/province [33] 0 0
Leipzig
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Germany
State/province [34] 0 0
Munchen
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Israel
State/province [35] 0 0
Tel Aviv
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Netherlands
State/province [36] 0 0
Nijmegen
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Netherlands
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Rotterdam
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Norway
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Oslo
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Poland
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Lodz
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Spain
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Barcelona
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Spain
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Majadahonda
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Switzerland
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Bern
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Switzerland
State/province [43] 0 0
Zurich
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United Kingdom
State/province [44] 0 0
Hants

Funding & Sponsors
Primary sponsor type
Other
Name
Yale University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Abbott Medical Devices
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Boston Scientific Corporation
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The registry will obtain information to determine the safety of sports participation for
patients with defibrillators (ICDs).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00637754
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel Lampert, MD
Address 0 0
Yale University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00637754