Clinical trial NCT00637754: Safety of Sports for Patients With Implantable Cardioverter-Defibrillators
Official title: Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrhythmias
Keywords: ICD
Sports
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Abbott Medical Devices
name: Boston Scientific Corporation
First posted: 2008-03-18
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages of 10 and 60 years who have defibrillators who participate in competitive (organized sports at any level) or dangerous sports.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
timeFrame: four years
Secondary outcomes:
measure: System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination
timeFrame: four years.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pediatric Cardiology Consultants
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Heart Clinic Arkansas
state: Arkansas
city: Los Angeles
country: United States
facility: Foundation for the Advancement of Cardiovascular Therapy
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Arrhythmia Center of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Johns Hopkins University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Wichita
country: United States
facility: Cypress Heart
state: Kansas
city: Towson
country: United States
facility: Midatlantic Cardiovascular Associates, PA
state: Maryland
city: Boston
country: United States
facility: Tufts-New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Heart, PC
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: Park Nicollet
state: Minnesota
city: Roseville
country: United States
facility: Children's Hospital and Clinics of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Research Foundation
state: Ohio
city: Portland
country: United States
facility: Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_
state: Oregon
city: Wynnewood
country: United States
facility: Main Line Health Heart Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital, Mebourne LTD
state: Victoria
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
city: Arlon
country: Belgium
facility: Clin.du sud-Luxembourg
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre University Hospital
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Praha 4
country: Czech Republic
facility: IKEM
city: Rennes
country: France
facility: CHRU-Hopital de Pontchaillou
city: Toulouse
country: France
facility: Dlinique Pasteur
city: Leipzig
country: Germany
facility: Univeristy of Leipzig Heart Centre
city: Munchen
country: Germany
facility: Klinikum Bogenhausen
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Hospital Nijmegen
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Oslo
country: Norway
facility: Rikshospitalet Oslo
city: Lodz
country: Poland
facility: Sterling Memorial University Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic-University of Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Bern
country: Switzerland
facility: University of Bern
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Hants
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Yale University
name: Rachel Lampert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.