Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

NCT ID: NCT00637754

Last Updated: 2015-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Rachel Lampert

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Lampert, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Arizona Pediatric Cardiology Consultants

Phoenix, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

Heart Clinic Arkansas

Little Rock, Arkansas, United States

Site Status

Foundation for the Advancement of Cardiovascular Therapy

Los Angeles, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Arrhythmia Center of Connecticut

New Haven, Connecticut, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Johns Hopkins University

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Cypress Heart

Wichita, Kansas, United States

Site Status

Midatlantic Cardiovascular Associates, PA

Towson, Maryland, United States

Site Status

Tufts-New England Medical Center

Boston, Massachusetts, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Michigan Heart, PC

Ann Arbor, Michigan, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Park Nicollet

Minneapolis, Minnesota, United States

Site Status

Children's Hospital and Clinics of Minnesota

Roseville, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

The Ohio State University Research Foundation

Columbus, Ohio, United States

Site Status

Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_

Portland, Oregon, United States

Site Status

Main Line Health Heart Center

Wynnewood, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

St. Vincent's Hospital, Mebourne LTD

Fitzroy, Victoria, Australia

Site Status

OLV Hospital Aalst

Aalst, , Belgium

Site Status

Clin.du sud-Luxembourg

Arlon, , Belgium

Site Status

UZ Antwerpen

Edegem, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

The University of British Columbia

Vancouver, British Columbia, Canada

Site Status

London Health Sciences Centre University Hospital

London, Ontario, Canada

Site Status

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

Site Status

IKEM

Prague, , Czechia

Site Status

CHRU-Hopital de Pontchaillou

Rennes, , France

Site Status

Dlinique Pasteur

Toulouse, , France

Site Status

Univeristy of Leipzig Heart Centre

Leipzig, , Germany

Site Status

Klinikum Bogenhausen

München, , Germany

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Radboud University Hospital Nijmegen

Nijmegen, , Netherlands

Site Status

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status

Rikshospitalet Oslo

Oslo, , Norway

Site Status

Sterling Memorial University Hospital

Lodz, , Poland

Site Status

Hospital Clinic-University of Barcelona

Barcelona, , Spain

Site Status

Hospital Puerta de Hierro

Majadahonda, , Spain

Site Status

University of Bern

Bern, , Switzerland

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Southampton General Hospital

Hants, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Czechia France Germany Israel Netherlands Norway Poland Spain Switzerland United Kingdom

References

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Saarel EV, Law I, Berul CI, Ackerman MJ, Kanter RJ, Sanatani S, Cohen MI, Berger S, Fischbach PS, Burton DA, Dziura J, Brandt C, Simone L, Li F, Olshansky B, Cannom DS, Lampert RJ. Safety of Sports for Young Patients With Implantable Cardioverter-Defibrillators: Long-Term Results of the Multinational ICD Sports Registry. Circ Arrhythm Electrophysiol. 2018 Nov;11(11):e006305. doi: 10.1161/CIRCEP.118.006305.

Reference Type DERIVED
PMID: 30520349 (View on PubMed)

Other Identifiers

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0608001730

Identifier Type: -

Identifier Source: org_study_id

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