TerminatedNCT00683696EchoCRTUpdated Jan 17, 2018Results posted

Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

A Phase 2/3 interventional study of Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) in Heart Failure and Ventricular Dyssynchrony, sponsored by Biotronik, Inc.. Terminated at 122 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Biotronik, Inc. · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 1,680
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Heart Failure
Ventricular Dyssynchrony

Browse trials for

Heart Failure 5,701

Keywords

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

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 1,680 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Biotronik, Inc. is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 1,680 participants (actual)

Study arms

Experimental
CRT=ON
Cardiac Resynchronization Therapy activated.
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
Active comparator
CRT=OFF
Cardiac Resynchronization Therapy deactivated.
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)

Interventions

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

What researchers measure

Primary outcomes

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.
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
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.
Time frame: 6 months

Secondary outcomes

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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
Time frame: From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years

Results

Posted Apr 17, 2014

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.

Participant flow

Participant flow — Overall Study
Milestone	CRT=ON	CRT=OFF
Started	404	405
Completed	0	0
Not completed	404	405
Withdrew: Withdrawn due to study closure	337	338
Withdrew: Withdrawn prior to study closure	13	28
Withdrew: Lost to follow-up	5	6
Withdrew: Vital status follow-up only	3	3
Withdrew: Death	46	30

Outcome measures

PrimaryComposite 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.

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
Reported as:: Number · participants

Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death
participants	CRT=ON	CRT=OFF
Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death	116	102

PrimaryNumber 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.

Time frame:: 6 months
Reported as:: Number · participants

Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
participants	Subjects That Underwent an Implant Attempt
Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)	766

SecondaryRate 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).

Time frame:: Study duration from randomization to study exit
Reported as:: Number · Hospitalizations per subj-yr

Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Hospitalizations per subj-yr	CRT=ON	CRT=OFF
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)	0.36	0.28

SecondaryNew 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.

Time frame:: 6 months
Reported as:: Count of participants · Participants

New York Heart Association (NYHA) Classification Change
Participants	CRT=ON	CRT=OFF
Improved at least 1 Class	213	185
No Change	116	141
Deteriorated at least 1 Class	18	12

SecondaryChange 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.

Time frame:: Changes between baseline and 6 months
Reported as:: Mean · units on a scale

Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
units on a scale	CRT=ON	CRT=OFF
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up	-12.1 ± 21.9	-13.5 ± 21.4

SecondaryComposite 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.

Time frame:: Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)
Reported as:: Mean · Composite score

Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)
Composite score	CRT=ON	CRT=OFF
Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)	-1.6 ± 1.9	-1.5 ± 1.6

SecondaryNumber of Subjects With All-cause Mortality

Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.

Time frame:: From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years
Reported as:: Count of participants · Participants

Number of Subjects With All-cause Mortality
Participants	CRT=ON	CRT=OFF
Number of Subjects With All-cause Mortality	45	26

Adverse events

Collected over Study duration from date of implant to date of study exit, with a mean implant duration of 1.7 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CRT=ON	45/404 (11.1%)	259/404 (64.1%)	300/404 (74.3%)
CRT=OFF	26/405 (6.4%)	221/405 (54.6%)	274/405 (67.7%)

Most frequent serious events

Showing 10 of 53

Most frequent serious events
Event	CRT=ON	CRT=OFF
Worsening heart failureCardiac disorders	101/404	93/405
InfectionInfections and infestations	58/404	45/405
Gastrointestinal disorderGastrointestinal disorders	43/404	28/405
Other noncardiovascularGeneral disorders	40/404	36/405
Renal disorderRenal and urinary disorders	28/404	16/405
Atrial arrhythmiaCardiac disorders	27/404	25/405
Ventricular arrhythmiaCardiac disorders	26/404	22/405
Musculoskeletal disorderMusculoskeletal and connective tissue disorders	25/404	15/405
ICD leadCardiac disorders	23/404	13/405
Respiratory disorderRespiratory, thoracic and mediastinal disorders	14/404	22/405

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	CRT=ON	CRT=OFF
Non-cardiovascularGeneral disorders	203/404	201/405
Lead for left ventricular pacingCardiac disorders	49/404	10/405
Implant ProcedureSurgical and medical procedures	31/404	41/405
Atrial arrhythmiaCardiac disorders	39/404	35/405
Ventricular arrhythmiaCardiac disorders	33/404	25/405
DyspneaCardiac disorders	20/404	30/405
Worsening heart failureCardiac disorders	29/404	29/405
Chest painCardiac disorders	20/404	29/405
ICD leadCardiac disorders	28/404	6/405
HypotensionCardiac disorders	27/404	27/405

Baseline characteristics

Baseline characterisics were analzed for the randomized population.

Age, Continuous
Age, Continuous(years)	CRT=ON	CRT=OFF	Total
Mean	57.6 ± 12.9	58.3 ± 12.6	58.0 ± 12.7

Sex: Female, Male
Sex: Female, Male(Participants)	CRT=ON	CRT=OFF	Total
Female	110	114	224
Male	294	291	585

Region of Enrollment
Region of Enrollment(participants)	CRT=ON	CRT=OFF	Total
Portugal	4	3	7
United States	196	198	394
Spain	18	18	36
Austria	6	8	14
Israel	18	16	34
United Kingdom	19	18	37
Switzerland	11	11	22
Italy	4	4	8
France	10	11	21
Czech Republic	12	11	23
Canada	13	14	27
Poland	0	2	2
Belgium	6	6	12
Australia	12	11	23
Denmark	24	23	47
Germany	41	41	82
Netherlands	10	10	20

Study locations

122 sites

John Muir Medical Center
Concord, California 94520, United States
Cedars-Sinai Medical Center
Los Angeles, California 90048, United States
Desert Cardiology
Rancho Mirage, California 92270, United States
University of California San Francisco
San Francisco, California 94143, United States
Cardiology Associates Medical Group
Ventura, California 93003, United States
Hartford Hospital
Hartford, Connecticut 06102, United States
Osceola Regional Medical Center
Kissimmee, Florida 34741, United States
University of Miami
Miami, Florida 33136, United States
Tampa General Hospital
Tampa, Florida 33606, United States
Tampa General Medical Center
Tampa, Florida, United States
Piedmont Hospital
Atlanta, Georgia 30309, United States
Emory University
Atlanta, Georgia 30322, United States
Saint Joseph's Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois 60611, United States
St. Francis Medical Group
Indianapolis, Indiana 46237, United States
Community Heart and Vascular
Indianapolis, Indiana 46250, United States
Central Baptist Hospital
Lexington, Kentucky 40503, United States
Massachusetts General Hospital
Boston, Massachusetts 02114-2696, United States
Boston Medical Center
Boston, Massachusetts 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts 01655, United States
Bay Regional Medical Center
Bay City, Michigan 48708, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan 48910, United States
Michigan Heart, P.C./ St. Joseph Mercy Hospital
Ypsilanti, Michigan 48197, United States
United Heart and Vascular Center
Saint Paul, Minnesota 55102, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Kansas City Heart Foundation
Kansas City, Missouri 64132, United States
Research Medical Center
Kansas City, Missouri 64132, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University
Saint Louis, Missouri 63102, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015, United States
Montefiore Medical Center
Bronx, New York 10467, United States
St. Lukes-Roosevelt Hospital Center
New York, New York 10025, United States
University of Rochester
Rochester, New York 14642, United States
Stony Brook University Medical Center
Stony Brook, New York 11794, United States
Sanger Heart & Vascular Institute
Charlotte, North Carolina 28203, United States
Duke University
Durham, North Carolina, United States
Lindner Clinical Trial Center
Cincinnati, Ohio 45219, United States
University of Cincinnati
Cincinnati, Ohio 45219, United States
Cleveland Clinic
Cleveland, Ohio 44145, United States
The Ohio State University Richard M. Ross Heart Hospital
Columbus, Ohio 43210, United States
Promedica Northwest Ohio Cardiology Consultants
Toledo, Ohio 43615, United States
Oregon Health Sciences University
Portland, Oregon 97239, United States
Lehigh Valley Heart Specialists
Allentown, Pennsylvania 18103, United States
Drexel Cardiology
Philadelphia, Pennsylvania 19107, United States
Jefferson Heart Institute, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States
South Carolina Heart Center
Columbia, South Carolina 29204, United States
The Stern Cardiovascular Center
Memphis, Tennessee 38138, United States
Cardiology Center of Amarillo
Amarillo, Texas 79106, United States
Texas Cardiac Arrhythmia
Austin, Texas 78705, United States
Cardiology Associates of Corpus Christi
Corpus Christi, Texas 78404, United States
University of Virginia
Charlottesville, Virginia 22908, United States
INOVA Fairfax Hospital
Falls Church, Virginia 22042, United States
Bon Secours Heart & Vascular Institute
Mechanicsville, Virginia 23116, United States
Virginia Cardiovascular Specialists
Richmond, Virginia 23225, United States
Bon Secours Heart & Vascular Institute
Richmond, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Cardiovascular Associates Ltd
Virginia Beach, Virginia 23454, United States
Kootenai Heart Clinics
Spokane, Washington 99204, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin 53215, 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
St. Marien Hospital Lunen
Lunen, Germany
Klinikum Lüdenscheid
Lüdenscheid, Germany
University Hospital of Magdeburg
Magdeburg, Germany
Barzilai Medical Center
Ashkelon, Israel
Soroka Medical Center
Beer Sheva, Israel
Hadassah Medical Organization
Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, Israel

Showing the first 100 of 122 sites across 17 countries.

References and documents

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. Erratum In: J Am Heart Assoc. 2018 Jun 17;7(12):e004259. doi: 10.1161/JAHA.117.004259. PubMed 29807890 ↗
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. PubMed 29566816 ↗
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. PubMed 27282848 ↗
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. PubMed 23998714 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00683696
Lead sponsor: Biotronik, Inc.
Collaborators: University of Zurich
Responsible party: Sponsor
First posted: May 23, 2008
Start date: Aug 2008
Primary completion: Mar 2013
Completion: Mar 2013
Results posted: Apr 17, 2014
Last update: Jan 17, 2018

Study contacts

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

Jagmeet Singh, MD

principal investigator · Principal Investigator (USA) at Massachusetts General Hospital, MA, USA

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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