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Clinical Trials/NCT00637754
NCT00637754CompletedNot Applicable

Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry

Yale University54 sites in 12 countries400 target enrollmentStarted: September 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
54
Primary Endpoint
Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
10 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.

Time Frame: four years

Secondary Outcomes

  • System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination(four years.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rachel Lampert

Principal Investigator

Yale University

Study Sites (54)

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