Heart Arrhythmias
Conditions
Keywords
ICD, Sports
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.
Interventions
None listed
Sponsors
Medtronic
Abbott Medical Devices
Boston Scientific Corporation
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock. | four years |
Secondary
| Measure | Time frame |
|---|---|
| System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination | four years. |
Countries
Australia, Belgium, Canada, Czechia, France, Germany, Israel, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed