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Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)

NCT00187291 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2023-07-13

No results posted yet for this study

Summary

The ABCD clinical study is designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained tachycardia. Patients undergo both the TWA test and EP study and receive an Implantable Cardioverter Defibrillator (ICD)if either of the tests show the patient is at risk. The patient is then followed for 2 years. The incidence of a ventricular tachyarrhythmia events and total mortality are to be evaluated over the duration of the study.

Conditions

  • Ischemic Cardiomyopathy
  • LV Dysfunction

Interventions

DEVICE

T-Wave Alternans test

Sponsors & Collaborators

  • Cambridge Heart Inc.

    collaborator INDUSTRY

  • MetroHealth Medical Center

    collaborator OTHER

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • David Rosenbaum, MD · MetroHealth Medical Center

  • Otto Costantini, MD · MetroHealth Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2006-07-31
Completion
2006-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00187291 on ClinicalTrials.gov