Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

NCT00683696 | Terminated Phase 2 Results DMC

• 1 other identifier: EchoCRT
• Study Type: interventional
• Target: 1,680
• Locations: 16 countries
• Sites: 117

Brief 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.

Conditions

Heart Failure; Ventricular Dyssynchrony

Keywords

Cardiac Resynchronization Therapy; Heart Failure; Ventricular Dyssynchrony; Mechanical Dyssynchrony; Intraventricular Dyssynchrony; Echocardiography; Normal QRS; Heart Disease; EchoCRT

Outcome Measures

Primary Outcomes (2)

• Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death

  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)

  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 Outcomes (5)

• Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)

  Study duration from randomization to study exit

• New York Heart Association (NYHA) Classification Change

  6 months

• Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up

  Changes between baseline and 6 months

• Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)

  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

  From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years

Study Arms (2)

CRT=ON

EXPERIMENTAL

Cardiac Resynchronization Therapy activated.

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

CRT=OFF

ACTIVE COMPARATOR

Cardiac Resynchronization Therapy deactivated.

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

Interventions

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

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.

Also known as: Lumax HF-T CRT-D system

CRT=OFF; CRT=ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik, Inc.: lead
• University of Zurich: collaborator

Study Sites (122)

John Muir Medical Center

Concord, California, 94520, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Desert Cardiology

Rancho Mirage, California, 92270, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Osceola Regional Medical Center

Kissimmee, Florida, 34741, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Tampa General Medical Center

Tampa, Florida, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Saint Joseph's Hospital

Atlanta, Georgia, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

St. Francis Medical Group

Indianapolis, Indiana, 46237, United States

Location

Community Heart and Vascular

Indianapolis, Indiana, 46250, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Boston Medical Center

Boston, Massachusetts, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Thoracic & Cardiovascular Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

Michigan Heart, P.C./ St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

United Heart and Vascular Center

Saint Paul, Minnesota, 55102, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, United States

Location

Kansas City Heart Foundation

Kansas City, Missouri, 64132, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Research Medical Center

Kansas City, Missouri, United States

Location

Washington University

St Louis, Missouri, 63102, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

St. Lukes-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Sanger Heart & Vascular Institute

Charlotte, North Carolina, 28203, United States

Location

Duke University

Durham, North Carolina, United States

Location

Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44145, United States

Location

The Ohio State University Richard M. Ross Heart Hospital

Columbus, Ohio, 43210, United States

Location

Promedica Northwest Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Heart Specialists

Allentown, Pennsylvania, 18103, United States

Location

Drexel Cardiology

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Heart Institute, Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

The Stern Cardiovascular Center

Memphis, Tennessee, 38138, United States

Location

Cardiology Center of Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

Cardiology Associates of Corpus Christi

Corpus Christi, Texas, 78404, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Bon Secours Heart & Vascular Institute

Mechanicsville, Virginia, 23116, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23225, United States

Location

Bon Secours Heart & Vascular Institute

Richmond, Virginia, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, United States

Location

Cardiovascular Associates Ltd

Virginia Beach, Virginia, 23454, United States

Location

Kootenai Heart Clinics

Spokane, Washington, 99204, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

Flinders Medical Center Adelaide

Adelaide, Australia

Location

Princess Alexandra Hospital

Brisbane, Australia

Location

St. Vincent's Hospital

Melbourne, Australia

Location

Sir Charles Gairdner Hospital

Nedland, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

LKH Universitatsklinikum Graz

Graz, Austria

Location

OLV Hospital (OLV Ziekenhuis) Aalst

Aalst, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

UHN Toronto General Hospital

Toronto, Ontario, Canada

Location

Edmonton Cardiology

Edmonton, Canada

Location

Olomouc University Hospital

Olomouc, Czechia

Location

IKEM - Institute for Clinical and Experimental Medicine

Prague, Czechia

Location

Na Homolce Hospital

Prague, Czechia

Location

Aalborg Sygehus

Aalborg, Denmark

Location

Skejby Sygehus Aarhus

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Gentofte Hospital

Hellerup, Denmark

Location

Nouvelles Cliniques Nantes

Nantes, France

Location

CHU Pontchaillou de Rennes

Rennes, France

Location

CHU Charles Nicolle

Rouen, France

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Charite Campus Virchow Klinikum

Berlin, Germany

Location

Judisches Krankenhaus Berlin

Berlin, Germany

Location

Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau

Bernau, Germany

Location

Alfried Krupp Krankenhaus

Essen, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, Germany

Location

Westdeutsches Herzzentrum Essen

Essen, Germany

Location

Asklepios Klinik St. Georg Hamburg

Hamburg, Germany

Location

Universitares Herzzentrum Hamburg GmbH

Hamburg, Germany

Location

Universitatsklinikum Jena

Jena, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, Germany

Location

St. Marien Hospital Lunen

Lünen, Germany

Location

University Hospital of Magdeburg

Magdeburg, Germany

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

A.O.U. Consorziale Policlinico di Bari

Bari, Italy

Location

A.O. Spedali Civili di Brescia

Brescia, Italy

Location

P.O. Santa Maria di Loreto Nuovo

Naples, Italy

Location

A.O.U. Maggiore della Carita

Novara, Italy

Location

VU MC Amsterdam

Amsterdam, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Instytut Kardiologii

Warsaw, Poland

Location

4 Wojskowy Szpital Kliniczny

Wroclaw, Poland

Location

Hospital Santa Maria de Lisboa

Lisbon, Portugal

Location

Hospital Santa Marta

Lisbon, Portugal

Location

University of Alicante General Hospital

Alicante, Spain

Location

Hospital Clinic of Barcelona

Barcelona, Spain

Location

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Location

CHU Vaudois Lausanne

Lausanne, Switzerland

Location

Triemli Hospital (Stadtspital Triemli)

Zurich, Switzerland

Location

University of Zurich Hospital

Zurich, Switzerland

Location

University Hospitals of Coventry and Warwickshire

Coventry, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

St. George's Hospital

London, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

Russells Hall Hospital

West Midlands, United Kingdom

Location

Related Publications (4)

• Varma N, Sogaard P, Bax JJ, Abraham WT, Borer JS, Dickstein K, Singh JP, Gras D, Holzmeister J, Brugada J, Ruschitzka F. Interaction of Left Ventricular Size and Sex on Outcome of Cardiac Resynchronization Therapy Among Patients With a Narrow QRS Duration in the EchoCRT Trial. J Am Heart Assoc. 2018 May 27;7(11):e009592. doi: 10.1161/JAHA.118.009592.

  PMID: 29807890 DERIVED

• Tayal B, Gorcsan J 3rd, Bax JJ, Risum N, Olsen NT, Singh JP, Abraham WT, Borer JS, Dickstein K, Gras D, Krum H, Brugada J, Robertson M, Ford I, Holzmeister J, Ruschitzka F, Sogaard P. Cardiac Resynchronization Therapy in Patients With Heart Failure and Narrow QRS Complexes. J Am Coll Cardiol. 2018 Mar 27;71(12):1325-1333. doi: 10.1016/j.jacc.2018.01.042.

  PMID: 29566816 DERIVED

• Steffel J, Varma N, Robertson M, Singh JP, Bax JJ, Borer JS, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J, Brugada J, Abraham WT, Ruschitzka F. Effect of Gender on Outcomes After Cardiac Resynchronization Therapy in Patients With a Narrow QRS Complex: A Subgroup Analysis of the EchoCRT Trial. Circ Arrhythm Electrophysiol. 2016 Jun;9(6):e003924. doi: 10.1161/CIRCEP.115.003924.

  PMID: 27282848 DERIVED

• Ruschitzka F, Abraham WT, Singh JP, Bax JJ, Borer JS, Brugada J, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J; EchoCRT Study Group. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N Engl J Med. 2013 Oct 10;369(15):1395-405. doi: 10.1056/NEJMoa1306687. Epub 2013 Sep 2.

  PMID: 23998714 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Interventions

Defibrillators, Implantable; Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants; Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Limitations and Caveats

Endpoint results should be interpreted with caution and take into consideration the early study closure and subsequent reduction in sample size (809 vs. 1258) and events (218 vs. 381). These changes impact the statistical power of the findings.

Results Point of Contact

• Title: Kelly Mohr
• Organization: Biotronik, Inc.

kelly.mohr@biotronik.com

800-547-0394

Study Officials

• Frank Ruschitzka, MD

  University of Zurich, Switzerland

  STUDY CHAIR

• Johannes Holzmeister, MD

  University of Zurich, Switzerland

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: May 23, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 17, 2018
• Results First Posted: April 17, 2014

Record last verified: 2018-01

Locations

IT (4); PT (2); AU (1); DK (4); IL (5); NL (2); ES (2); CA (2); CZ (3); CH (4); FR (3); US (62); DE (14); PL (2); BE (2); GB (5)