Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

This study is currently recruiting participants.

Verified by Yale University, January 2009

First Received: March 11, 2008 Last Updated: January 13, 2009 History of Changes

Sponsor:	Yale University
Collaborators:	Medtronic St. Jude Medical Boston Scientific Corporation
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00637754

Purpose

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

Condition
Patients With ICD's Who Are Participating in Sports.

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

Resource links provided by NLM:

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by Yale University:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	880
Study Start Date:	September 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (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 two 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

People 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 years
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)
Adults over the age of 60 (to maintain a more homogeneous 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 27 Study Locations

Sponsors and Collaborators

Yale University

Medtronic

St. Jude Medical

Boston Scientific Corporation

Investigators

Principal Investigator:

Rachel Lampert, MD

Yale University

More Information

No publications provided

Responsible Party:	Yale University ( Rachel Lampert, MD Associate Professor of Medicine )
Study ID Numbers:	0608001730
Study First Received:	March 11, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00637754 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

ICD
Sports

ClinicalTrials.gov processed this record on November 20, 2009