Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
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
Country [27] 0 0
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
Country [34] 0 0
Germany
State/province [34] 0 0
Munchen
Country [35] 0 0
Israel
State/province [35] 0 0
Tel Aviv
Country [36] 0 0
Netherlands
State/province [36] 0 0
Nijmegen
Country [37] 0 0
Netherlands
State/province [37] 0 0
Rotterdam
Country [38] 0 0
Norway
State/province [38] 0 0
Oslo
Country [39] 0 0
Poland
State/province [39] 0 0
Lodz
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona
Country [41] 0 0
Spain
State/province [41] 0 0
Majadahonda
Country [42] 0 0
Switzerland
State/province [42] 0 0
Bern
Country [43] 0 0
Switzerland
State/province [43] 0 0
Zurich
Country [44] 0 0
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/study/NCT00637754
Trial related presentations / publications
Saarel EV, Law I, Berul CI, Ackerman MJ, Kanter RJ, Sanatani S, Cohen MI, Berger S, Fischbach PS, Burton DA, Dziura J, Brandt C, Simone L, Li F, Olshansky B, Cannom DS, Lampert RJ. Safety of Sports for Young Patients With Implantable Cardioverter-Defibrillators: Long-Term Results of the Multinational ICD Sports Registry. Circ Arrhythm Electrophysiol. 2018 Nov;11(11):e006305. doi: 10.1161/CIRCEP.118.006305.
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/study/NCT00637754