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Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637754
First Posted: March 18, 2008
Last Update Posted: June 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medtronic
St. Jude Medical
Boston Scientific Corporation
Information provided by (Responsible Party):
Rachel Lampert, Yale University
  Purpose
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

Condition
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 Rachel Lampert, 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.
  Eligibility

Information from the National Library of Medicine

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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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637754


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

Additional Information:
Responsible Party: Rachel Lampert, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00637754     History of Changes
Other Study ID Numbers: 0608001730
First Submitted: March 11, 2008
First Posted: March 18, 2008
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by Rachel Lampert, Yale University:
ICD
Sports

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes