Heart Arrhythmias Clinical Trial
Official title:
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry
| Verified date | June 2015 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 10 Years to 60 Years |
| Eligibility |
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 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Australia | St. Vincent's Hospital, Mebourne LTD | Fitzroy | Victoria |
| Belgium | OLV Hospital Aalst | Aalst | |
| Belgium | Clin.du sud-Luxembourg | Arlon | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | UZ Leuven | Leuven | |
| Canada | London Health Sciences Centre University Hospital | London | Ontario |
| Canada | Institut de Cardiologie de Montreal | Montreal | Quebec |
| Canada | The University of British Columbia | Vancouver | British Columbia |
| Czech Republic | IKEM | Praha 4 | |
| France | CHRU-Hopital de Pontchaillou | Rennes | |
| France | Dlinique Pasteur | Toulouse | |
| Germany | Univeristy of Leipzig Heart Centre | Leipzig | |
| Germany | Klinikum Bogenhausen | Munchen | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Netherlands | Radboud University Hospital Nijmegen | Nijmegen | |
| Netherlands | Erasmus Medisch Centrum | Rotterdam | |
| Norway | Rikshospitalet Oslo | Oslo | |
| Poland | Sterling Memorial University Hospital | Lodz | |
| Spain | Hospital Clinic-University of Barcelona | Barcelona | |
| Spain | Hospital Puerta de Hierro | Majadahonda | |
| Switzerland | University of Bern | Bern | |
| Switzerland | University Hospital Zurich | Zurich | |
| United Kingdom | Southampton General Hospital | Hants | |
| United States | Michigan Heart, PC | Ann Arbor | Michigan |
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| United States | Children's Hospital Boston | Boston | Massachusetts |
| United States | Tufts-New England Medical Center | Boston | Massachusetts |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Johns Hopkins University | Chicago | Illinois |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | The Ohio State University Research Foundation | Columbus | Ohio |
| United States | Duke University | Durham | North Carolina |
| United States | University of Iowa | Iowa City | Iowa |
| United States | Heart Clinic Arkansas | Little Rock | Arkansas |
| United States | Foundation for the Advancement of Cardiovascular Therapy | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
| United States | Park Nicollet | Minneapolis | Minnesota |
| United States | Arrhythmia Center of Connecticut | New Haven | Connecticut |
| United States | Arizona Pediatric Cardiology Consultants | Phoenix | Arizona |
| United States | Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_ | Portland | Oregon |
| United States | Children's Hospital and Clinics of Minnesota | Roseville | Minnesota |
| United States | University of Utah | Salt Lake City | Utah |
| United States | University of California, San Francisco | San Francisco | California |
| United States | University of Washington | Seattle | Washington |
| United States | Washington University | St. Louis | Missouri |
| United States | Midatlantic Cardiovascular Associates, PA | Towson | Maryland |
| United States | University of Arizona | Tucson | Arizona |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | George Washington University | Washington | District of Columbia |
| United States | Walter Reed Army Medical Center | Washington | District of Columbia |
| United States | Cypress Heart | Wichita | Kansas |
| United States | Main Line Health Heart Center | Wynnewood | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University | Boston Scientific Corporation, Medtronic, St. Jude Medical |
United States, Australia, Belgium, Canada, Czech Republic, France, Germany, Israel, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock. | four years | Yes | |
| Secondary | System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination | four years. | Yes |