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CompletedNCT00637754Updated Jun 11, 2015

Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

An observational study in Heart Arrhythmias, sponsored by Yale University. Completed at 54 sites in 14 countries. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-06-11.

Sponsored by Yale University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
10 Years to 60 Years
Sex
All
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Study summary

The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

Read the 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.

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Conditions studied

  • Heart Arrhythmias

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Keywords

  • ICD
  • Sports
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In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's enrollment of 400 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
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What researchers measure

Primary outcomes

  1. Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.

    Time frame: four years

Secondary outcomes

  1. System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination

    Time frame: four years.

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Study locations

54 sites
  • Arizona Pediatric Cardiology Consultants
    Phoenix, Arizona 85006, United States
  • University of Arizona
    Tucson, Arizona 85719, United States
  • Heart Clinic Arkansas
    Little Rock, Arkansas 72205, United States
  • Foundation for the Advancement of Cardiovascular Therapy
    Los Angeles, California 90017, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • University of California, San Francisco
    San Francisco, California 94103, United States
  • Arrhythmia Center of Connecticut
    New Haven, Connecticut 06551, United States
  • Children's National Medical Center
    Washington, District of Columbia 20010, United States
  • George Washington University
    Washington, District of Columbia 20052, United States
  • Walter Reed Army Medical Center
    Washington, District of Columbia 20852, United States
  • Children's Healthcare of Atlanta
    Atlanta, Georgia 30329, United States
  • Johns Hopkins University
    Chicago, Illinois 60693, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • Cypress Heart
    Wichita, Kansas 67226, United States
  • Midatlantic Cardiovascular Associates, PA
    Towson, Maryland 21204, United States
  • Tufts-New England Medical Center
    Boston, Massachusetts 02111, United States
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
  • Michigan Heart, PC
    Ann Arbor, Michigan 48106, United States
  • Minneapolis Heart Institute Foundation
    Minneapolis, Minnesota 55407, United States
  • Park Nicollet
    Minneapolis, Minnesota 55416, United States
  • Children's Hospital and Clinics of Minnesota
    Roseville, Minnesota 55113, United States
  • Washington University
    St. Louis, Missouri 63110, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • The Ohio State University Research Foundation
    Columbus, Ohio 43210, United States
  • Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_
    Portland, Oregon 97232, United States
  • Main Line Health Heart Center
    Wynnewood, Pennsylvania 19096, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • University of Utah
    Salt Lake City, Utah 84158, United States
  • University of Washington
    Seattle, Washington 98195, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53201, United States
  • St. Vincent's Hospital, Mebourne LTD
    Fitzroy, Victoria 3065, Australia
  • OLV Hospital Aalst
    Aalst, Belgium
  • Clin.du sud-Luxembourg
    Arlon, Belgium
  • UZ Antwerpen
    Edegem, Belgium
  • UZ Leuven
    Leuven, Belgium
  • The University of British Columbia
    Vancouver, British Columbia V6T 1Z3, Canada
  • London Health Sciences Centre University Hospital
    London, Ontario N6A 5W9, Canada
  • Institut de Cardiologie de Montreal
    Montreal, Quebec H1T 1C8, Canada
  • IKEM
    Praha 4, Czech Republic
  • CHRU-Hopital de Pontchaillou
    Rennes, France
  • Dlinique Pasteur
    Toulouse, France
  • Univeristy of Leipzig Heart Centre
    Leipzig, Germany
  • Klinikum Bogenhausen
    Munchen, Germany
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
  • Radboud University Hospital Nijmegen
    Nijmegen, Netherlands
  • Erasmus Medisch Centrum
    Rotterdam, Netherlands
  • Rikshospitalet Oslo
    Oslo, Norway
  • Sterling Memorial University Hospital
    Lodz, Poland
  • Hospital Clinic-University of Barcelona
    Barcelona, Spain
  • Hospital Puerta de Hierro
    Majadahonda, Spain
  • University of Bern
    Bern, Switzerland
  • University Hospital Zurich
    Zurich, Switzerland
  • Southampton General Hospital
    Hants, United Kingdom
08

References and documents

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. PubMed 30520349 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00637754
Lead sponsor
Yale University
Collaborators
Medtronic, Abbott Medical Devices, Boston Scientific Corporation
Responsible party
Rachel Lampert (Principal Investigator, Yale University) — Principal investigator
First posted
Mar 18, 2008
Start date
Sep 2006
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Jun 11, 2015

Study contacts

Rachel Lampert, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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