Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
NCT ID: NCT00683696
Last Updated: 2018-01-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
1680 participants
INTERVENTIONAL
2008-08-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CRT=ON
Cardiac Resynchronization Therapy activated.
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.
CRT=OFF
Cardiac Resynchronization Therapy deactivated.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Biotronik, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Ruschitzka, MD
Role: STUDY_CHAIR
University of Zurich, Switzerland
Johannes Holzmeister, MD
Role: STUDY_CHAIR
University of Zurich, Switzerland
William Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator (USA) at The Ohio State University, OH, USA
Jagmeet Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator (USA) at Massachusetts General Hospital, MA, USA
Locations
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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
Piedmont Hospital
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Saint Joseph's Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
St. Francis Medical Group
Indianapolis, Indiana, United States
Community Heart and Vascular
Indianapolis, Indiana, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Bay Regional Medical Center
Bay City, Michigan, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Michigan Heart, P.C./ St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
United Heart and Vascular Center
Saint Paul, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Kansas City Heart Foundation
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
St. Lukes-Roosevelt Hospital Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Richard M. Ross Heart Hospital
Columbus, Ohio, United States
Promedica Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, United States
Drexel Cardiology
Philadelphia, Pennsylvania, United States
Jefferson Heart Institute, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
South Carolina Heart Center
Columbia, South Carolina, United States
The Stern Cardiovascular Center
Memphis, Tennessee, United States
Cardiology Center of Amarillo
Amarillo, Texas, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
Cardiology Associates of Corpus Christi
Corpus Christi, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
INOVA Fairfax Hospital
Falls Church, Virginia, United States
Bon Secours Heart & Vascular Institute
Mechanicsville, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Bon Secours Heart & Vascular Institute
Richmond, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Cardiovascular Associates Ltd
Virginia Beach, Virginia, United States
Kootenai Heart Clinics
Spokane, Washington, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
Flinders Medical Center Adelaide
Adelaide, , Australia
Princess Alexandra Hospital
Brisbane, , Australia
St. Vincent's Hospital
Melbourne, , Australia
Sir Charles Gairdner Hospital
Nedland, , Australia
Royal Perth Hospital
Perth, , Australia
LKH Universitatsklinikum Graz
Graz, , Austria
OLV Hospital (OLV Ziekenhuis) Aalst
Aalst, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
UHN Toronto General Hospital
Toronto, Ontario, Canada
Edmonton Cardiology
Edmonton, , Canada
Olomouc University Hospital
Olomouc, , Czechia
IKEM - Institute for Clinical and Experimental Medicine
Prague, , Czechia
Na Homolce Hospital
Prague, , Czechia
Aalborg Sygehus
Aalborg, , Denmark
Skejby Sygehus Aarhus
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Nouvelles Cliniques Nantes
Nantes, , France
CHU Pontchaillou de Rennes
Rennes, , France
CHU Charles Nicolle
Rouen, , France
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Charite Campus Virchow Klinikum
Berlin, , Germany
Judisches Krankenhaus Berlin
Berlin, , Germany
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
Bernau, , Germany
Alfried Krupp Krankenhaus
Essen, , Germany
Elisabeth-Krankenhaus Essen
Essen, , Germany
Westdeutsches Herzzentrum Essen
Essen, , Germany
Asklepios Klinik St. Georg Hamburg
Hamburg, , Germany
Universitares Herzzentrum Hamburg GmbH
Hamburg, , Germany
Universitatsklinikum Jena
Jena, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Klinikum Lüdenscheid
Lüdenscheid, , Germany
St. Marien Hospital Lunen
Lünen, , Germany
University Hospital of Magdeburg
Magdeburg, , Germany
Barzilai Medical Center
Ashkelon, , Israel
Soroka Medical Center
Beersheba, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
A.O.U. Consorziale Policlinico di Bari
Bari, , Italy
A.O. Spedali Civili di Brescia
Brescia, , Italy
P.O. Santa Maria di Loreto Nuovo
Naples, , Italy
A.O.U. Maggiore della Carita
Novara, , Italy
VU MC Amsterdam
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Instytut Kardiologii
Warsaw, , Poland
4 Wojskowy Szpital Kliniczny
Wroclaw, , Poland
Hospital Santa Maria de Lisboa
Lisbon, , Portugal
Hospital Santa Marta
Lisbon, , Portugal
University of Alicante General Hospital
Alicante, , Spain
Hospital Clinic of Barcelona
Barcelona, , Spain
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
CHU Vaudois Lausanne
Lausanne, , Switzerland
Triemli Hospital (Stadtspital Triemli)
Zurich, , Switzerland
University of Zurich Hospital
Zurich, , Switzerland
University Hospitals of Coventry and Warwickshire
Coventry, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
St. George's Hospital
London, , United Kingdom
St. Thomas' Hospital
London, , United Kingdom
Russells Hall Hospital
West Midlands, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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EchoCRT
Identifier Type: -
Identifier Source: org_study_id
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