ST Segment Detection Study

NCT ID: NCT00930969

Last Updated: 2019-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-03-31

Brief Summary

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The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable Cardioverter Defibrillator (ICD) who have coronary artery disease.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ICD

Subjects implanted with an ICD.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is indicated for an ICD implantation
* AND subject must meet ONE of the following:

* Prior acute coronary event
* Previously underwent Percutaneous Coronary Intervention (PCI) or stent procedure
* Multivessel disease
* Positive stress test completed with evidence of ischemic heart disease, as determined by physician, and no subsequent successful revascularization

Exclusion Criteria

* Subject is currently dependent on ventricular pacing
* Subject has Left Bundle Brunch Block (LBBB) and/or wide QRS
* Subject has chronic Atrial Fibrillation (AF)
* Subject has dementia
* Subject is indicated for a single chamber device
* Subject requires a right sided or abdominal ICD implant
* Subject is pregnant or in fertile age without secure birth control
* Subject has New York Heart Association (NYHA) class IV or refractory heart failure
* Subject is not expected to survive greater than 12 months
* Subject is participating in other confounding research studies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Crossley, MD

Role: PRINCIPAL_INVESTIGATOR

St. Thomas Research Institute and University of Tennessee College of Medicine Nashville, TN

Timothy Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute Foundation Minneapolis, MN

Locations

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Anchorage, Alaska, United States

Site Status

Brandon, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Davenport, Iowa, United States

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Boston, Massachusetts, United States

Site Status

Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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Mineola, New York, United States

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Stony Brook, New York, United States

Site Status

Gastonia, North Carolina, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Nashville, Tennessee, United States

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Austin, Texas, United States

Site Status

Burlington, Vermont, United States

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Richmond, Virginia, United States

Site Status

Morgantown, West Virginia, United States

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Linz, , Austria

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Liège, , Belgium

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Copenhagen, , Denmark

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Berlin, , Germany

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Heidelberg, , Germany

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Nuremberg, , Germany

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Zwolle, , Netherlands

Site Status

Kristiansand, , Norway

Site Status

Countries

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United States Austria Belgium Denmark Germany Netherlands Norway

Other Identifiers

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ST Detect

Identifier Type: -

Identifier Source: org_study_id

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