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OpenTrials
Completed

NCT Number: NCT00637754

Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

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

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Key information

Conditions

Heart Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent's Hospital, Mebourne LTD, Fitzroy, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: four years

Secondary outcomes

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

    Time frame: four years.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Abbott Medical Devices
  • Boston Scientific Corporation
  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2008
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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