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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Zürich
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation
Medtronic
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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