Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

June 10, 2015 updated by: Rachel Lampert, Yale University

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital, Mebourne LTD
  • Belgium
      • Aalst, Belgium
        • OLV Hospital Aalst
      • Arlon, Belgium
        • Clin.du sud-Luxembourg
      • Edegem, Belgium
        • UZ Antwerpen
      • Leuven, Belgium
        • UZ Leuven
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • The University of British Columbia
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre University Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal
  • Czech Republic
      • Praha 4, Czech Republic
        • IKEM
  • France
      • Rennes, France
        • CHRU-Hopital de Pontchaillou
      • Toulouse, France
        • Dlinique Pasteur
  • Germany
      • Leipzig, Germany
        • Univeristy of Leipzig Heart Centre
      • Munchen, Germany
        • Klinikum Bogenhausen
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Hospital Nijmegen
      • Rotterdam, Netherlands
        • Erasmus Medisch Centrum
  • Norway
      • Oslo, Norway
        • Rikshospitalet Oslo
  • Poland
      • Lodz, Poland
        • Sterling Memorial University Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Clinic-University of Barcelona
      • Majadahonda, Spain
        • Hospital Puerta de Hierro
  • Switzerland
      • Bern, Switzerland
        • University of Bern
      • Zurich, Switzerland
        • University Hospital Zurich
  • United Kingdom
      • Hants, United Kingdom
        • Southampton General Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Arizona Pediatric Cardiology Consultants
      • Tucson, Arizona, United States, 85719
        • University of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Heart Clinic Arkansas
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90017
        • Foundation for the Advancement of Cardiovascular Therapy
      • San Francisco, California, United States, 94103
        • University of California, San Francisco
    • Connecticut
      • New Haven, Connecticut, United States, 06551
        • Arrhythmia Center of Connecticut
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
      • Washington, District of Columbia, United States, 20052
        • George Washington University
      • Washington, District of Columbia, United States, 20852
        • Walter Reed Army Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60693
        • Johns Hopkins University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Cypress Heart
    • Maryland
      • Towson, Maryland, United States, 21204
        • Midatlantic Cardiovascular Associates, Pa
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
      • Boston, Massachusetts, United States, 02111
        • Tufts-New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Heart, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Minneapolis, Minnesota, United States, 55416
        • Park Nicollet
      • Roseville, Minnesota, United States, 55113
        • Children's Hospital and Clinics of Minnesota
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Research Foundation
    • Oregon
      • Portland, Oregon, United States, 97232
        • Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health Heart Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Utah
      • Salt Lake City, Utah, United States, 84158
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
Time Frame: four years
four years

Secondary Outcome Measures

Outcome Measure
Time Frame
System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination
Time Frame: four years.
four years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Boston Scientific Corporation
Medtronic
Abbott Medical Devices

Investigators

  • Principal Investigator: Rachel Lampert, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0608001730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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