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Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

NCT00683696•Biotronik, Inc.

Summary

The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication, with a narrow QRS width (\< 130 ms) and echocardiographic evidence of ventricular dyssynchrony.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women 18 years of age or older.
•Understand the nature of the procedure.
•Give written informed consent.
•Willing and able to complete all testing required by the clinical protocol.
•Indication for an implantable cardioverter defibrillator (ICD).
•NYHA class III-IV within the last three months prior to enrollment and at baseline (at baseline only: also Stage C according to ACC/AHA guidelines).
•Stable optimal pharmacologic therapy for HF.
•An ejection fraction ≤ 35% within one year prior to enrollment and confirmed on the baseline echocardiogram.
•Increased left ventricular dimension, defined as LVEDD ≥ 55 mm.
•Resting QRS duration \< 130 ms evidenced by a historical 12-lead ECG prior to enrollment and at baseline.
+3 more criteria

Exclusion Criteria

•Implanted pacemaker or defibrillator with \>10% ventricular pacing, as demonstrated by device statistics averaged over at least the last three months prior to enrollment.
•Women who are pregnant, lactating, or planning to become pregnant during the course of the trial.
•Bradycardia pacing indication.
•Surgically correctable primary valvular heart disease, i.e. aortic stenosis, torn cordae, or flail segment.
•Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 months prior to enrollment.
•Enzyme-positive myocardial infarction within the past 3 months prior to enrollment.
•Angiographic evidence of coronary disease, candidates for coronary revascularization likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the next 3 months.
•Irreversible brain damage from preexisting cerebral disease.
•Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.
•Permanent second or third degree heart block.
+13 more criteria

Locations (122)

John Muir Medical Center

Concord, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Desert Cardiology

Rancho Mirage, California, United States

University of California San Francisco

San Francisco, California, United States

Cardiology Associates Medical Group

Ventura, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Osceola Regional Medical Center

Kissimmee, Florida, United States

University of Miami

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Tampa General Medical Center

Tampa, Florida, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

March 1, 2013

Completion Date

March 1, 2013

Last Updated

January 17, 2018

Enrollment

1,680

ACTUAL participants

Conditions

Heart FailureVentricular Dyssynchrony

Interventions

Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

Inclusion Criteria

Exclusion Criteria

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