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Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

This study is currently recruiting participants.
Verified August 2012 by Yale University
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: August 8, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Yale University:

Estimated Enrollment: 400
Study Start Date: September 2006
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637754

Contacts
Contact: Cheryl L Barth, BS 866-207-9813 icdsports.registry@yale.edu

  Show 26 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:
Enrollment information  This link exits the ClinicalTrials.gov site

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: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
ICD
Sports

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

ClinicalTrials.gov processed this record on May 16, 2013