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Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medtronic
St. Jude Medical
Boston Scientific Corporation
Information provided by (Responsible Party):
Rachel Lampert, Yale University
ClinicalTrials.gov Identifier:
NCT00637754
First received: March 11, 2008
Last updated: January 15, 2014
Last verified: January 2014
  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 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 400
Study Start Date: September 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Rachel Lampert, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00637754     History of Changes
Other Study ID Numbers: 0608001730
Study First Received: March 11, 2008
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
ICD
Sports

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

ClinicalTrials.gov processed this record on November 20, 2014