Heart ArrhythmiasNCT00637754
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators
An observational study of Heart Arrhythmias, run by Yale University at 54 sites in 14 countries.
Trial summary
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs). Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Heart Arrhythmias
- How many people
- 400 participants
- Where
- 54 sitesin 14 countries
- Study dates
- Sep 2006to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
54 sites in 14 countries.
54 sites in 14 countries
United States31 sites
Michigan Heart, PC
Ann Arbor, Michigan, 48106
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Children's Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Johns Hopkins University
Chicago, Illinois, 60693
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University Research Foundation
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
University of Iowa
Iowa City, Iowa, 52242
Heart Clinic Arkansas
Little Rock, Arkansas, 72205
Foundation for the Advancement of Cardiovascular Therapy
Los Angeles, California, 90017
University of Southern California
Los Angeles, California, 90033
Medical College of Wisconsin
Milwaukee, Wisconsin, 53201
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Park Nicollet
Minneapolis, Minnesota, 55416
Arrhythmia Center of Connecticut
New Haven, Connecticut, 06551
Arizona Pediatric Cardiology Consultants
Phoenix, Arizona, 85006
Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_
Portland, Oregon, 97232
Children's Hospital and Clinics of Minnesota
Roseville, Minnesota, 55113
University of Utah
Salt Lake City, Utah, 84158
University of California, San Francisco
San Francisco, California, 94103
University of Washington
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63110
Midatlantic Cardiovascular Associates, PA
Towson, Maryland, 21204
University of Arizona
Tucson, Arizona, 85719
Children's National Medical Center
Washington D.C., District of Columbia, 20010
George Washington University
Washington D.C., District of Columbia, 20052
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20852
Cypress Heart
Wichita, Kansas, 67226
Main Line Health Heart Center
Wynnewood, Pennsylvania, 19096
Belgium4 sites
OLV Hospital Aalst
Aalst
Clin.du sud-Luxembourg
Arlon
UZ Antwerpen
Edegem
UZ Leuven
Leuven
Canada3 sites
London Health Sciences Centre University Hospital
London, Ontario, N6A 5W9
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
The University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Germany2 sites
Univeristy of Leipzig Heart Centre
Leipzig
Klinikum Bogenhausen
München
Netherlands2 sites
Radboud University Hospital Nijmegen
Nijmegen
Erasmus Medisch Centrum
Rotterdam
Spain2 sites
Hospital Clinic-University of Barcelona
Barcelona
Hospital Puerta de Hierro
Majadahonda
Switzerland2 sites
University of Bern
Bern
University Hospital Zurich
Zurich
Australia1 site
St. Vincent's Hospital, Mebourne LTD
Fitzroy, Victoria, 3065
About this study
Official title: 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).
Read the 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.
- Conditions
- Heart Arrhythmias
- Keywords
- ICD, Sports
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
Measured: four years
Secondary outcomes (1)
System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination
Measured: four years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startSep 2006
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Abbott Medical Devices, Boston Scientific Corporation
- Responsible party
- Principal investigator, Rachel Lampert, Yale University
- Investigators
- Rachel Lampert, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637754
- Sponsor's protocol ID
- 0608001730
- Status last verified
- Jun 2015
- First submitted
- 11 Mar 2008
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30520349
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry
- ClinicalTrials.gov ID
- NCT00637754
- Acronym / sponsor ID
- 0608001730
- Conditions
- Heart Arrhythmias
- Keywords
- ICD, Sports
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Medtronic, Abbott Medical Devices, Boston Scientific Corporation
- Study start
- Sep 2006
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
Time frame: four years
1 secondary outcome
System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination
Time frame: four years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Derived from this study: PubMed 30520349Saarel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Lampert, MD principal investigator
Yale University
54 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrhythmias, run by Yale University at 54 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Belgium, Canada, France, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock. (time frame: four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.