Safety of Sports for Patients With Implantable Cardioverter-Defibrillators
- Conditions
- Heart Arrhythmias
- Registration Number
- NCT00637754
- Lead Sponsor
- Yale University
- Brief Summary
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).
- Detailed Description
Patients who are participating in sports who have defibrillators will be invited to participate in a prospective registry to determine the rate of adverse events occurring during sporting activities. Patients will be followed for four years and adverse events quantified. Yale is the coordinating center for this multicenter registry.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock. four years
- Secondary Outcome Measures
Name Time Method System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination four years.
Trial Locations
- Locations (54)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Washington University
🇺🇸St. Louis, Missouri, United States
UZ Antwerpen
🇧🇪Edegem, Belgium
Foundation for the Advancement of Cardiovascular Therapy
🇺🇸Los Angeles, California, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Johns Hopkins University
🇺🇸Chicago, Illinois, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Michigan Heart, PC
🇺🇸Ann Arbor, Michigan, United States
UZ Leuven
🇧🇪Leuven, Belgium
Radboud University Hospital Nijmegen
🇳🇱Nijmegen, Netherlands
Institut de Cardiologie de Montreal
🇨🇦Montreal, Quebec, Canada
Southampton General Hospital
🇬🇧Hants, United Kingdom
University of Iowa
🇺🇸Iowa City, Iowa, United States
Midatlantic Cardiovascular Associates, PA
🇺🇸Towson, Maryland, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Arrhythmia Center of Connecticut
🇺🇸New Haven, Connecticut, United States
St. Vincent's Hospital, Mebourne LTD
🇦🇺Fitzroy, Victoria, Australia
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Tufts-New England Medical Center
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Dlinique Pasteur
🇫🇷Toulouse, France
Hospital Puerta de Hierro
🇪🇸Majadahonda, Spain
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital and Clinics of Minnesota
🇺🇸Roseville, Minnesota, United States
OLV Hospital Aalst
🇧🇪Aalst, Belgium
Hospital Clinic-University of Barcelona
🇪🇸Barcelona, Spain
Klinikum Bogenhausen
🇩🇪Munchen, Germany
Park Nicollet
🇺🇸Minneapolis, Minnesota, United States
London Health Sciences Centre University Hospital
🇨🇦London, Ontario, Canada
Clin.du sud-Luxembourg
🇧🇪Arlon, Belgium
CHRU-Hopital de Pontchaillou
🇫🇷Rennes, France
University of Bern
🇨🇭Bern, Switzerland
Arizona Pediatric Cardiology Consultants
🇺🇸Phoenix, Arizona, United States
University of Southern California
🇺🇸Los Angeles, California, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Cypress Heart
🇺🇸Wichita, Kansas, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
The Ohio State University Research Foundation
🇺🇸Columbus, Ohio, United States
Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_
🇺🇸Portland, Oregon, United States
Main Line Health Heart Center
🇺🇸Wynnewood, Pennsylvania, United States
University of Washington
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Univeristy of Leipzig Heart Centre
🇩🇪Leipzig, Germany
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
IKEM
🇨🇿Praha 4, Czech Republic
University Hospital Zurich
🇨🇭Zurich, Switzerland
Duke University
🇺🇸Durham, North Carolina, United States
Rikshospitalet Oslo
🇳🇴Oslo, Norway
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Sterling Memorial University Hospital
🇵🇱Lodz, Poland