Safety of Sports for Patients With Implantable Cardiovert... | NCT00637754

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Mar 11, 2008

First Submission Date that Met QC Criteria

Mar 11, 2008

First Posted Date

Mar 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2015

Last Update Posted Date

Jun 11, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rachel Lampert, Principal Investigator, Yale UniversityPrincipal Investigator

Lead Sponsor

Yale UniversityOTHER

Collaborators

Name	Class
Medtronic	INDUSTRY
Abbott Medical Devices	INDUSTRY
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Lampert, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Pediatric Cardiology Consultants		Phoenix	Arizona	85006	United States
University of Arizona

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30520349	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms