AnalyST Treadmill Study

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

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-02-28

Brief Summary

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The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).

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Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ICD Implant

Implantation of a commercially available AnalyST or AnalyST Accel ICD

Group Type OTHER

ICD Implantation

Intervention Type DEVICE

Implantation of a commercially available AnalyST or AnalyST Accel ICD

Interventions

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ICD Implantation

Implantation of a commercially available AnalyST or AnalyST Accel ICD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
* Patient has documented ischemic heart disease.

Exclusion Criteria

* Patient has an indication for ventricular pacing;
* Patient has chronotropic incompetence or insufficiency;
* Patient has a contraindication to stress testing;
* Patient is physically unable to complete the stress test protocol;
* The patient has persistent or permanent atrial fibrillation (AF);
* Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason;
* Patient is pregnant;
* Patient is minor (\< 18 years old).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No