Heart FailurePhase 2/3EchoCRTNCT00683696
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
A Phase 2/3 study testing Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) in people with Heart Failure and Ventricular Dyssynchrony, run by Biotronik, Inc. at 122 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Dyssynchrony
- What is being tested?
- Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,680 participants
- Where
- 122 sitesin 17 countries
- Study dates
- Aug 2008to Mar 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
122 sites in 17 countries.
122 sites in 17 countries
United States62 sites
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, 18103
Cardiology Center of Amarillo
Amarillo, Texas, 79106
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University
Atlanta, Georgia, 30322
Saint Joseph's Hospital
Atlanta, Georgia
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Bay Regional Medical Center
Bay City, Michigan, 48708
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Boston Medical Center
Boston, Massachusetts
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28203
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44145
South Carolina Heart Center
Columbia, South Carolina, 29204
The Ohio State University Richard M. Ross Heart Hospital
Columbus, Ohio, 43210
John Muir Medical Center
Concord, California, 94520
Cardiology Associates of Corpus Christi
Corpus Christi, Texas, 78404
Duke University
Durham, North Carolina
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
Hartford Hospital
Hartford, Connecticut, 06102
St. Francis Medical Group
Indianapolis, Indiana, 46237
Community Heart and Vascular
Indianapolis, Indiana, 46250
Kansas City Heart Foundation
Kansas City, Missouri, 64132
Research Medical Center
Kansas City, Missouri, 64132
Research Medical Center
Kansas City, Missouri
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
Central Baptist Hospital
Lexington, Kentucky, 40503
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Bon Secours Heart & Vascular Institute
Mechanicsville, Virginia, 23116
The Stern Cardiovascular Center
Memphis, Tennessee, 38138
University of Miami
Miami, Florida, 33136
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
St. Lukes-Roosevelt Hospital Center
New York, New York, 10025
Drexel Cardiology
Philadelphia, Pennsylvania, 19107
Jefferson Heart Institute, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97239
Desert Cardiology
Rancho Mirage, California, 92270
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225
Bon Secours Heart & Vascular Institute
Richmond, Virginia
Virginia Cardiovascular Specialists
Richmond, Virginia
University of Rochester
Rochester, New York, 14642
United Heart and Vascular Center
Saint Paul, Minnesota, 55102
University of California San Francisco
San Francisco, California, 94143
Kootenai Heart Clinics
Spokane, Washington, 99204
Washington University
St Louis, Missouri, 63102
Stony Brook University Medical Center
Stony Brook, New York, 11794
Tampa General Hospital
Tampa, Florida, 33606
Tampa General Medical Center
Tampa, Florida
Montefiore Medical Center
The Bronx, New York, 10467
Promedica Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43615
North Mississippi Medical Center
Tupelo, Mississippi
Cardiology Associates Medical Group
Ventura, California, 93003
Cardiovascular Associates Ltd
Virginia Beach, Virginia, 23454
University of Massachusetts
Worcester, Massachusetts, 01655
Michigan Heart, P.C./ St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197
Germany14 sites
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Charite Campus Virchow Klinikum
Berlin
Judisches Krankenhaus Berlin
Berlin
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
Bernau
Alfried Krupp Krankenhaus
Essen
Elisabeth-Krankenhaus Essen
Essen
Westdeutsches Herzzentrum Essen
Essen
Asklepios Klinik St. Georg Hamburg
Hamburg
Universitares Herzzentrum Hamburg GmbH
Hamburg
Universitatsklinikum Jena
Jena
Herzzentrum Leipzig GmbH
Leipzig
Klinikum Lüdenscheid
Lüdenscheid
St. Marien Hospital Lunen
Lünen
University Hospital of Magdeburg
Magdeburg
Australia5 sites
Flinders Medical Center Adelaide
Adelaide
Princess Alexandra Hospital
Brisbane
St. Vincent's Hospital
Melbourne
Sir Charles Gairdner Hospital
Nedland
Royal Perth Hospital
Perth
Israel5 sites
Barzilai Medical Center
Ashkelon
Soroka Medical Center
Beersheba
Hadassah Medical Organization
Jerusalem
Sourasky Medical Center
Tel Aviv
Sheba Medical Center
Tel HaShomer
United Kingdom5 sites
University Hospitals of Coventry and Warwickshire
Coventry
Glenfield Hospital
Leicester
St. George's Hospital
London
St. Thomas' Hospital
London
Russells Hall Hospital
West Midlands
Denmark4 sites
Aalborg Sygehus
Aalborg
Skejby Sygehus Aarhus
Aarhus
Rigshospitalet
Copenhagen
Gentofte Hospital
Hellerup
Italy4 sites
A.O.U. Consorziale Policlinico di Bari
Bari
A.O. Spedali Civili di Brescia
Brescia
P.O. Santa Maria di Loreto Nuovo
Naples
A.O.U. Maggiore della Carita
Novara
Switzerland4 sites
Hopitaux Universitaires de Geneve
Geneva
CHU Vaudois Lausanne
Lausanne
Triemli Hospital (Stadtspital Triemli)
Zurich
University of Zurich Hospital
Zurich
Czechia3 sites
Olomouc University Hospital
Olomouc
IKEM - Institute for Clinical and Experimental Medicine
Prague
Na Homolce Hospital
Prague
France3 sites
Nouvelles Cliniques Nantes
Nantes
CHU Pontchaillou de Rennes
Rennes
CHU Charles Nicolle
Rouen
Belgium2 sites
OLV Hospital (OLV Ziekenhuis) Aalst
Aalst
Universitair Ziekenhuis Brussel
Brussels
Canada2 sites
Edmonton Cardiology
Edmonton
UHN Toronto General Hospital
Toronto, Ontario
Netherlands2 sites
VU MC Amsterdam
Amsterdam
Leiden University Medical Center
Leiden
Portugal2 sites
Hospital Santa Maria de Lisboa
Lisbon
Hospital Santa Marta
Lisbon
Spain2 sites
University of Alicante General Hospital
Alicante
Hospital Clinic of Barcelona
Barcelona
About this study
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
- Being tested
- Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
- Keywords
- Cardiac Resynchronization Therapy, Heart Failure, Ventricular Dyssynchrony, Mechanical Dyssynchrony, Intraventricular Dyssynchrony, Echocardiography, Normal QRS, Heart Disease, EchoCRT
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)Device
Also called Lumax HF-T CRT-D system
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.
| Study group | Role | What they receive |
|---|---|---|
| CRT=ON | Experimental | Cardiac Resynchronization Therapy activated. Receives: Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) |
| CRT=OFF | Active comparator | Cardiac Resynchronization Therapy deactivated. Receives: Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
Measured: Study duration from randomization to study exit
New York Heart Association (NYHA) Classification Change
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.
Measured: 6 months
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
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.
Measured: Changes between baseline and 6 months
Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)
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.
Measured: 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
Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
Measured: From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Frank Ruschitzka, MD, Study chair, University of Zurich, SwitzerlandJohannes Holzmeister, MD, Study chair, University of Zurich, SwitzerlandWilliam Abraham, MD, Principal investigator, Principal Investigator (USA) at The Ohio State University, OH, USAJagmeet Singh, MD, Principal investigator, Principal Investigator (USA) at Massachusetts General Hospital, MA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683696
- Sponsor's protocol ID
- EchoCRT
- Acronym
- EchoCRT
- Status last verified
- Jan 2018
- First submitted
- 30 Aug 2007
- Last updated
- 17 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29807890Tayal 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.
PubMed 29566816Steffel 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.
PubMed 27282848Ruschitzka 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.
PubMed 23998714
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
- ClinicalTrials.gov ID
- NCT00683696
- Acronym / sponsor ID
- EchoCRT / EchoCRT
- Conditions
- Heart Failure, Ventricular Dyssynchrony
- Keywords
- Cardiac Resynchronization Therapy, Heart Failure, Ventricular Dyssynchrony, Mechanical Dyssynchrony, Intraventricular Dyssynchrony, Echocardiography, Normal QRS, Heart Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,680 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Study start
- Aug 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 17 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT=ON | Experimental | Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)Cardiac Resynchronization Therapy activated. |
| CRT=OFF | Active comparator | Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)Cardiac Resynchronization Therapy deactivated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)Also: Lumax HF-T CRT-D systemAll 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. | Device | CRT=OFF, CRT=ON |
Primary outcome
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.
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.
5 secondary outcomes
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Time frame: Study duration from randomization to study exit
New York Heart Association (NYHA) Classification Change
Time frame: 6 months
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
Time frame: 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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29807890Varma 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.
- Derived from this study: PubMed 29566816Tayal 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.
- Derived from this study: PubMed 27282848Steffel 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.
- Derived from this study: PubMed 23998714Ruschitzka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Ruschitzka, MD study chair
University of Zurich, Switzerland
Johannes Holzmeister, MD study chair
University of Zurich, Switzerland
William Abraham, MD principal investigator
Principal Investigator (USA) at The Ohio State University, OH, USA
122 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) in people with Heart Failure and Ventricular Dyssynchrony, run by Biotronik, Inc. at 122 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in United States, Germany, Australia, Israel, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683696, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.