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Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

This study has been completed.
St. Jude Medical
Boston Scientific Corporation
Information provided by (Responsible Party):
Rachel Lampert, Yale University Identifier:
First received: March 11, 2008
Last updated: June 10, 2015
Last verified: June 2015
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

Heart Arrhythmias

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock. [ Time Frame: four years ]

Secondary Outcome Measures:
  • System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination [ Time Frame: four years. ]

Enrollment: 400
Study Start Date: September 2006
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00637754

  Show 54 Study Locations
Sponsors and Collaborators
Yale University
St. Jude Medical
Boston Scientific Corporation
Principal Investigator: Rachel Lampert, MD Yale University
  More Information

Additional Information:
Responsible Party: Rachel Lampert, Principal Investigator, Yale University Identifier: NCT00637754     History of Changes
Other Study ID Numbers: 0608001730
Study First Received: March 11, 2008
Last Updated: June 10, 2015

Keywords provided by Yale University:

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 25, 2017