Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) (EchoCRT)

January 12, 2018 updated by: Biotronik, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1680

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Flinders Medical Center Adelaide
      • Brisbane, Australia
        • Princess Alexandra Hospital
      • Melbourne, Australia
        • St. Vincent's Hospital
      • Nedland, Australia
        • Sir Charles Gairdner Hospital
      • Perth, Australia
        • Royal Perth Hospital
  • Austria
      • Graz, Austria
        • LKH Universitätsklinikum Graz
  • Belgium
      • Aalst, Belgium
        • OLV Hospital (OLV Ziekenhuis) Aalst
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel
  • Canada
      • Edmonton, Canada
        • Edmonton Cardiology
    • Ontario
      • Toronto, Ontario, Canada
        • UHN Toronto General Hospital
  • Czechia
      • Olomouc, Czechia
        • Olomouc University Hospital
      • Prague, Czechia
        • Na Homolce Hospital
      • Prague, Czechia
        • IKEM - Institute for Clinical and Experimental Medicine
  • Denmark
      • Aalborg, Denmark
        • Aalborg Sygehus
      • Aarhus, Denmark
        • Skejby Sygehus Aarhus
      • Copenhagen, Denmark
        • Rigshospitalet
      • Hellerup, Denmark
        • Gentofte Hospital
  • France
      • Nantes, France
        • Nouvelles Cliniques Nantes
      • Rennes, France
        • CHU Pontchaillou de Rennes
      • Rouen, France
        • CHU Charles Nicolle
  • Germany
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum NRW
      • Berlin, Germany
        • Charite Campus Virchow Klinikum
      • Berlin, Germany
        • Judisches Krankenhaus Berlin
      • Bernau, Germany
        • Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
      • Essen, Germany
        • Westdeutsches Herzzentrum Essen
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen
      • Essen, Germany
        • Alfried Krupp Krankenhaus
      • Hamburg, Germany
        • Asklepios Klinik St. Georg Hamburg
      • Hamburg, Germany
        • Universitäres Herzzentrum Hamburg GmbH
      • Jena, Germany
        • Universitätsklinikum Jena
      • Leipzig, Germany
        • Herzzentrum Leipzig GmbH
      • Lunen, Germany
        • St. Marien Hospital Lünen
      • Lüdenscheid, Germany
        • Klinikum Lüdenscheid
      • Magdeburg, Germany
        • University Hospital of Magdeburg
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Beer Sheva, Israel
        • Soroka Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Organization
      • Tel Aviv, Israel
        • Sourasky Medical Center
      • Tel Hashomer, Israel
        • Sheba Medical Center
  • Italy
      • Bari, Italy
        • A.O.U. Consorziale Policlinico di Bari
      • Brescia, Italy
        • A.O. Spedali Civili di Brescia
      • Naples, Italy
        • P.O. Santa Maria di Loreto Nuovo
      • Novara, Italy
        • A.O.U. Maggiore della Carità
  • Netherlands
      • Amsterdam, Netherlands
        • VU MC Amsterdam
      • Leiden, Netherlands
        • Leiden University Medical Center
  • Poland
      • Warsaw, Poland
        • Instytut Kardiologii
      • Wroclaw, Poland
        • 4 Wojskowy Szpital Kliniczny
  • Portugal
      • Lisbon, Portugal
        • Hospital Santa Maria de Lisboa
      • Lisbon, Portugal
        • Hospital Santa Marta
  • Spain
      • Alicante, Spain
        • University of Alicante General Hospital
      • Barcelona, Spain
        • Hospital Clinic of Barcelona
  • Switzerland
      • Geneve, Switzerland
        • Hôpitaux Universitaires de Genève
      • Lausanne, Switzerland
        • Chu Vaudois Lausanne
      • Zurich, Switzerland
        • Triemli Hospital (Stadtspital Triemli)
      • Zurich, Switzerland
        • University of Zurich Hospital
  • United Kingdom
      • Coventry, United Kingdom
        • University Hospitals of Coventry and Warwickshire
      • Leicester, United Kingdom
        • Glenfield Hospital
      • London, United Kingdom
        • St. Thomas' Hospital
      • London, United Kingdom
        • St. George's Hospital
      • West Midlands, United Kingdom
        • Russells Hall Hospital
  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Rancho Mirage, California, United States, 92270
        • Desert Cardiology
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Ventura, California, United States, 93003
        • Cardiology Associates Medical Group
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Osceola Regional Medical Center
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Tampa, Florida, United States
        • Tampa General Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States
        • Saint Joseph's Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Medical Group
      • Indianapolis, Indiana, United States, 46250
        • Community Heart and Vascular
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02114-2696
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States
        • Boston Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Bay Regional Medical Center
      • Lansing, Michigan, United States, 48910
        • Thoracic & Cardiovascular Healthcare Foundation
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart, P.C./ St. Joseph Mercy Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • United Heart and Vascular Center
    • Mississippi
      • Tupelo, Mississippi, United States
        • North Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64132
        • Kansas City Heart Foundation
      • Kansas City, Missouri, United States
        • Research Medical Center
      • Saint Louis, Missouri, United States, 63102
        • Washington University
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10025
        • St. Lukes-Roosevelt Hospital Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Sanger Heart & Vascular Institute
      • Durham, North Carolina, United States
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45219
        • Lindner Clinical Trial Center
      • Cleveland, Ohio, United States, 44145
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Richard M. Ross Heart Hospital
      • Toledo, Ohio, United States, 43615
        • ProMedica Northwest Ohio Cardiology Consultants
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Heart Specialists
      • Philadelphia, Pennsylvania, United States, 19107
        • Drexel Cardiology
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Heart Institute, Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
    • Tennessee
      • Memphis, Tennessee, United States, 38138
        • The Stern Cardiovascular Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Cardiology Center of Amarillo
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia
      • Corpus Christi, Texas, United States, 78404
        • Cardiology Associates of Corpus Christi
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Mechanicsville, Virginia, United States, 23116
        • Bon Secours Heart & Vascular Institute
      • Richmond, Virginia, United States, 23225
        • Virginia Cardiovascular Specialists
      • Richmond, Virginia, United States
        • Bon Secours Heart & Vascular Institute
      • Richmond, Virginia, United States
        • Virginia Cardiovascular Specialists
      • Virginia Beach, Virginia, United States, 23454
        • Cardiovascular Associates Ltd
    • Washington
      • Spokane, Washington, United States, 99204
        • Kootenai Heart Clinics
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

  • Ventricular dyssynchrony assessed by echocardiography locally and confirmed by the echo core lab. One of the two following criteria has to be present to include the subject in the study:

    • Intra-left ventricular dyssynchrony measured by color Tissue Doppler Imaging (TDI) with an opposing wall delay of ≥ 80 ms in the 4-chamber or apical long-axis view.
    • Speckle-tracking radial strain septal-posterior wall delay ≥ 130 ms.

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.
  • Chagas disease.
  • Persistent or paroxysmal atrial fibrillation within one month prior to enrollment.
  • Expected to receive heart transplantation within six months.
  • Current inotropic therapy.
  • Acutely decompensated heart failure.
  • Contrast dye allergy and unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
  • Life expectancy of less than six months.
  • Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer).
  • Significant renal insufficiency defined as a serum creatinine > 2.5 mg/dL (> 221 µmol/L) within the last four weeks prior to enrollment..
  • Liver failure, defined as three times the upper limit of normal for aminotransferases.
  • Participation in any other clinical trial.
  • Unable to return for follow-up visits due to distance from the clinic.
  • Do not anticipate being a resident of the area for the scheduled duration of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRT=ON
Cardiac Resynchronization Therapy activated.
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF.
Other Names:
  • Lumax HF-T CRT-D system
Active Comparator: CRT=OFF
Cardiac Resynchronization Therapy deactivated.
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF.
Other Names:
  • Lumax HF-T CRT-D system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death
Time Frame: From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years
The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.
From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years
Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
Time Frame: 6 months
The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Time Frame: Study duration from randomization to study exit
Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
Study duration from randomization to study exit
New York Heart Association (NYHA) Classification Change
Time Frame: 6 months

Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.

NYHA classes:

Class I - Subjects with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation,dyspnea, or anginal pain.

Class II - Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III - Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV - Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
6 months
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
Time Frame: Changes between baseline and 6 months
Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. Therefore, a negative change in QOL score from baseline to 6 months represents an improvement in quality of life, while a positive change in QOL score from baseline to 6 months represents a worsening in quality of life.
Changes between baseline and 6 months
Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)
Time Frame: Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)

Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.

This composite endpoint used a weighted scoring scale based on the African-American Heart Failure Trial (A-HeFT) study Endpoint Score. (Taylor, AL, Ziesche, S, Yancy, C, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. N Engl J Med 2004; 351:2049-57.)

Composite Endpoint Scoring:

Vital Status:

Death (-3),

Survival to end of trial (0),

Hospitalization:

1st hospitalization for HF (-1),

No hospitalization (0),

QOL score:*

Improvement by ≥ 10 units (+2),

Improvement by 5-9 units (+1),

Change by < 5 units (0),

Worsening by 5-9 units (-1),

Worsening by ≥ 10 (-2).

Possible total score -6 to +2.

*QOL score details are provided in Secondary Outcome Measure 5.
Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)
Number of Subjects With All-cause Mortality
Time Frame: From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years
Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik, Inc.

Collaborators

University of Zurich

Investigators

  • Study Chair: Frank Ruschitzka, MD, University of Zurich, Switzerland
  • Study Chair: Johannes Holzmeister, MD, University of Zurich, Switzerland
  • Principal Investigator: William Abraham, MD, Principal Investigator (USA) at The Ohio State University, OH, USA
  • Principal Investigator: Jagmeet Singh, MD, Principal Investigator (USA) at Massachusetts General Hospital, MA, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

May 21, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EchoCRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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