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Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) (EchoCRT)

Primary Purpose

Heart Failure, Ventricular Dyssynchrony

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
Sponsored by
Biotronik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, Heart Failure, Ventricular Dyssynchrony, Mechanical Dyssynchrony, Intraventricular Dyssynchrony, Echocardiography, Normal QRS, Heart Disease, EchoCRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women 18 years of age or older.
  • Understand the nature of the procedure.
  • Give written informed consent.
  • Willing and able to complete all testing required by the clinical protocol.
  • Indication for an implantable cardioverter defibrillator (ICD).
  • NYHA class III-IV within the last three months prior to enrollment and at baseline (at baseline only: also Stage C according to ACC/AHA guidelines).
  • Stable optimal pharmacologic therapy for HF.
  • An ejection fraction ≤ 35% within one year prior to enrollment and confirmed on the baseline echocardiogram.
  • Increased left ventricular dimension, defined as LVEDD ≥ 55 mm.
  • Resting QRS duration < 130 ms evidenced by a historical 12-lead ECG prior to enrollment and at baseline.

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

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

Exclusion Criteria:

  • Implanted pacemaker or defibrillator with >10% ventricular pacing, as demonstrated by device statistics averaged over at least the last three months prior to enrollment.
  • Women who are pregnant, lactating, or planning to become pregnant during the course of the trial.
  • Bradycardia pacing indication.
  • Surgically correctable primary valvular heart disease, i.e. aortic stenosis, torn cordae, or flail segment.
  • Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 months prior to enrollment.
  • Enzyme-positive myocardial infarction within the past 3 months prior to enrollment.
  • Angiographic evidence of coronary disease, candidates for coronary revascularization likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the next 3 months.
  • Irreversible brain damage from preexisting cerebral disease.
  • Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.
  • Permanent second or third degree heart block.
  • Chagas disease.
  • Persistent or paroxysmal atrial fibrillation within one month prior to enrollment.
  • Expected to receive heart transplantation within six months.
  • Current inotropic therapy.
  • Acutely decompensated heart failure.
  • Contrast dye allergy and unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
  • Life expectancy of less than six months.
  • Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer).
  • Significant renal insufficiency defined as a serum creatinine > 2.5 mg/dL (> 221 µmol/L) within the last four weeks prior to enrollment..
  • Liver failure, defined as three times the upper limit of normal for aminotransferases.
  • Participation in any other clinical trial.
  • Unable to return for follow-up visits due to distance from the clinic.
  • Do not anticipate being a resident of the area for the scheduled duration of the trial.

Sites / Locations

  • John Muir Medical Center
  • Cedars-Sinai Medical Center
  • Desert Cardiology
  • University of California San Francisco
  • Cardiology Associates Medical Group
  • Hartford Hospital
  • Osceola Regional Medical Center
  • University of Miami
  • Tampa General Hospital
  • Tampa General Medical Center
  • Piedmont Hospital
  • Emory University
  • Saint Joseph's Hospital
  • Northwestern University
  • St. Francis Medical Group
  • Community Heart and Vascular
  • Central Baptist Hospital
  • Massachusetts General Hospital
  • Boston Medical Center
  • Beth Israel Deaconess Medical Center
  • Boston Medical Center
  • University of Massachusetts
  • Bay Regional Medical Center
  • Thoracic & Cardiovascular Healthcare Foundation
  • Michigan Heart, P.C./ St. Joseph Mercy Hospital
  • United Heart and Vascular Center
  • North Mississippi Medical Center
  • Kansas City Heart Foundation
  • Research Medical Center
  • Research Medical Center
  • Washington University
  • Deborah Heart and Lung Center
  • Montefiore Medical Center
  • St. Lukes-Roosevelt Hospital Center
  • University of Rochester
  • Stony Brook University Medical Center
  • Sanger Heart & Vascular Institute
  • Duke University
  • Lindner Clinical Trial Center
  • University of Cincinnati
  • Cleveland Clinic
  • The Ohio State University Richard M. Ross Heart Hospital
  • Promedica Northwest Ohio Cardiology Consultants
  • Oregon Health Sciences University
  • Lehigh Valley Heart Specialists
  • Drexel Cardiology
  • Jefferson Heart Institute, Thomas Jefferson University Hospital
  • University of Pittsburgh Medical Center
  • South Carolina Heart Center
  • The Stern Cardiovascular Center
  • Cardiology Center of Amarillo
  • Texas Cardiac Arrhythmia
  • Cardiology Associates of Corpus Christi
  • University of Virginia
  • INOVA Fairfax Hospital
  • Bon Secours Heart & Vascular Institute
  • Virginia Cardiovascular Specialists
  • Bon Secours Heart & Vascular Institute
  • Virginia Cardiovascular Specialists
  • Cardiovascular Associates Ltd
  • Kootenai Heart Clinics
  • Aurora Cardiovascular Services
  • Flinders Medical Center Adelaide
  • Princess Alexandra Hospital
  • St. Vincent's Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • LKH Universitatsklinikum Graz
  • OLV Hospital (OLV Ziekenhuis) Aalst
  • Universitair Ziekenhuis Brussel
  • UHN Toronto General Hospital
  • Edmonton Cardiology
  • Olomouc University Hospital
  • IKEM - Institute for Clinical and Experimental Medicine
  • Na Homolce Hospital
  • Aalborg Sygehus
  • Skejby Sygehus Aarhus
  • Rigshospitalet
  • Gentofte Hospital
  • Nouvelles Cliniques Nantes
  • CHU Pontchaillou de Rennes
  • CHU Charles Nicolle
  • Herz- und Diabeteszentrum NRW
  • Charite Campus Virchow Klinikum
  • Judisches Krankenhaus Berlin
  • Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
  • Alfried Krupp Krankenhaus
  • Elisabeth-Krankenhaus Essen
  • Westdeutsches Herzzentrum Essen
  • Asklepios Klinik St. Georg Hamburg
  • Universitares Herzzentrum Hamburg GmbH
  • Universitatsklinikum Jena
  • Herzzentrum Leipzig GmbH
  • St. Marien Hospital Lunen
  • Klinikum Lüdenscheid
  • University Hospital of Magdeburg
  • Barzilai Medical Center
  • Soroka Medical Center
  • Hadassah Medical Organization
  • Sourasky Medical Center
  • Sheba Medical Center
  • A.O.U. Consorziale Policlinico di Bari
  • A.O. Spedali Civili di Brescia
  • P.O. Santa Maria di Loreto Nuovo
  • A.O.U. Maggiore della Carita
  • VU MC Amsterdam
  • Leiden University Medical Center
  • Instytut Kardiologii
  • 4 Wojskowy Szpital Kliniczny
  • Hospital Santa Maria de Lisboa
  • Hospital Santa Marta
  • University of Alicante General Hospital
  • Hospital Clinic of Barcelona
  • Hopitaux Universitaires de Geneve
  • CHU Vaudois Lausanne
  • Triemli Hospital (Stadtspital Triemli)
  • University of Zurich Hospital
  • University Hospitals of Coventry and Warwickshire
  • Glenfield Hospital
  • St. George's Hospital
  • St. Thomas' Hospital
  • Russells Hall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRT=ON

CRT=OFF

Arm Description

Cardiac Resynchronization Therapy activated.

Cardiac Resynchronization Therapy deactivated.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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.
Number of Subjects With All-cause Mortality
Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.

Full Information

First Posted
August 30, 2007
Last Updated
January 12, 2018
Sponsor
Biotronik, Inc.
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00683696
Brief Title
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Acronym
EchoCRT
Official Title
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik, Inc.
Collaborators
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Dyssynchrony
Keywords
Cardiac Resynchronization Therapy, Heart Failure, Ventricular Dyssynchrony, Mechanical Dyssynchrony, Intraventricular Dyssynchrony, Echocardiography, Normal QRS, Heart Disease, EchoCRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1680 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT=ON
Arm Type
Experimental
Arm Description
Cardiac Resynchronization Therapy activated.
Arm Title
CRT=OFF
Arm Type
Active Comparator
Arm Description
Cardiac Resynchronization Therapy deactivated.
Intervention Type
Device
Intervention Name(s)
Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
Other Intervention Name(s)
Lumax HF-T CRT-D system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death
Description
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
Title
Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
Description
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 Outcome Measure Information:
Title
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Description
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
Title
New York Heart Association (NYHA) Classification Change
Description
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
Title
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
Description
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
Title
Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)
Description
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)
Title
Number of Subjects With All-cause Mortality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 years of age or older. Understand the nature of the procedure. Give written informed consent. Willing and able to complete all testing required by the clinical protocol. Indication for an implantable cardioverter defibrillator (ICD). NYHA class III-IV within the last three months prior to enrollment and at baseline (at baseline only: also Stage C according to ACC/AHA guidelines). Stable optimal pharmacologic therapy for HF. An ejection fraction ≤ 35% within one year prior to enrollment and confirmed on the baseline echocardiogram. Increased left ventricular dimension, defined as LVEDD ≥ 55 mm. Resting QRS duration < 130 ms evidenced by a historical 12-lead ECG prior to enrollment and at baseline. Ventricular dyssynchrony assessed by echocardiography locally and confirmed by the echo core lab. One of the two following criteria has to be present to include the subject in the study: Intra-left ventricular dyssynchrony measured by color Tissue Doppler Imaging (TDI) with an opposing wall delay of ≥ 80 ms in the 4-chamber or apical long-axis view. Speckle-tracking radial strain septal-posterior wall delay ≥ 130 ms. Exclusion Criteria: Implanted pacemaker or defibrillator with >10% ventricular pacing, as demonstrated by device statistics averaged over at least the last three months prior to enrollment. Women who are pregnant, lactating, or planning to become pregnant during the course of the trial. Bradycardia pacing indication. Surgically correctable primary valvular heart disease, i.e. aortic stenosis, torn cordae, or flail segment. Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 months prior to enrollment. Enzyme-positive myocardial infarction within the past 3 months prior to enrollment. Angiographic evidence of coronary disease, candidates for coronary revascularization likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the next 3 months. Irreversible brain damage from preexisting cerebral disease. Reversible non-ischemic cardiomyopathy such as acute viral myocarditis. Permanent second or third degree heart block. Chagas disease. Persistent or paroxysmal atrial fibrillation within one month prior to enrollment. Expected to receive heart transplantation within six months. Current inotropic therapy. Acutely decompensated heart failure. Contrast dye allergy and unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine. Life expectancy of less than six months. Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer). Significant renal insufficiency defined as a serum creatinine > 2.5 mg/dL (> 221 µmol/L) within the last four weeks prior to enrollment.. Liver failure, defined as three times the upper limit of normal for aminotransferases. Participation in any other clinical trial. Unable to return for follow-up visits due to distance from the clinic. Do not anticipate being a resident of the area for the scheduled duration of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Ruschitzka, MD
Organizational Affiliation
University of Zurich, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johannes Holzmeister, MD
Organizational Affiliation
University of Zurich, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Abraham, MD
Organizational Affiliation
Principal Investigator (USA) at The Ohio State University, OH, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jagmeet Singh, MD
Organizational Affiliation
Principal Investigator (USA) at Massachusetts General Hospital, MA, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Desert Cardiology
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Cardiology Associates Medical Group
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Osceola Regional Medical Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Tampa General Medical Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Francis Medical Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Community Heart and Vascular
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Thoracic & Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Michigan Heart, P.C./ St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
United Heart and Vascular Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Kansas City Heart Foundation
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63102
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
St. Lukes-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Sanger Heart & Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
The Ohio State University Richard M. Ross Heart Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Promedica Northwest Ohio Cardiology Consultants
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Heart Specialists
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Drexel Cardiology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Jefferson Heart Institute, Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
The Stern Cardiovascular Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Cardiology Center of Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Cardiac Arrhythmia
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Cardiology Associates of Corpus Christi
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Bon Secours Heart & Vascular Institute
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Virginia Cardiovascular Specialists
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Bon Secours Heart & Vascular Institute
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Virginia Cardiovascular Specialists
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Cardiovascular Associates Ltd
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Kootenai Heart Clinics
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Flinders Medical Center Adelaide
City
Adelaide
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
Country
Australia
Facility Name
St. Vincent's Hospital
City
Melbourne
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedland
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
LKH Universitatsklinikum Graz
City
Graz
Country
Austria
Facility Name
OLV Hospital (OLV Ziekenhuis) Aalst
City
Aalst
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
UHN Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Edmonton Cardiology
City
Edmonton
Country
Canada
Facility Name
Olomouc University Hospital
City
Olomouc
Country
Czechia
Facility Name
IKEM - Institute for Clinical and Experimental Medicine
City
Prague
Country
Czechia
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
Aalborg Sygehus
City
Aalborg
Country
Denmark
Facility Name
Skejby Sygehus Aarhus
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
Country
Denmark
Facility Name
Nouvelles Cliniques Nantes
City
Nantes
Country
France
Facility Name
CHU Pontchaillou de Rennes
City
Rennes
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen
Country
France
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
Country
Germany
Facility Name
Charite Campus Virchow Klinikum
City
Berlin
Country
Germany
Facility Name
Judisches Krankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
City
Bernau
Country
Germany
Facility Name
Alfried Krupp Krankenhaus
City
Essen
Country
Germany
Facility Name
Elisabeth-Krankenhaus Essen
City
Essen
Country
Germany
Facility Name
Westdeutsches Herzzentrum Essen
City
Essen
Country
Germany
Facility Name
Asklepios Klinik St. Georg Hamburg
City
Hamburg
Country
Germany
Facility Name
Universitares Herzzentrum Hamburg GmbH
City
Hamburg
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
Country
Germany
Facility Name
St. Marien Hospital Lunen
City
Lunen
Country
Germany
Facility Name
Klinikum Lüdenscheid
City
Lüdenscheid
Country
Germany
Facility Name
University Hospital of Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Soroka Medical Center
City
Beer Sheva
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
A.O.U. Consorziale Policlinico di Bari
City
Bari
Country
Italy
Facility Name
A.O. Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
P.O. Santa Maria di Loreto Nuovo
City
Naples
Country
Italy
Facility Name
A.O.U. Maggiore della Carita
City
Novara
Country
Italy
Facility Name
VU MC Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Instytut Kardiologii
City
Warsaw
Country
Poland
Facility Name
4 Wojskowy Szpital Kliniczny
City
Wroclaw
Country
Poland
Facility Name
Hospital Santa Maria de Lisboa
City
Lisbon
Country
Portugal
Facility Name
Hospital Santa Marta
City
Lisbon
Country
Portugal
Facility Name
University of Alicante General Hospital
City
Alicante
Country
Spain
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
Country
Spain
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve
Country
Switzerland
Facility Name
CHU Vaudois Lausanne
City
Lausanne
Country
Switzerland
Facility Name
Triemli Hospital (Stadtspital Triemli)
City
Zurich
Country
Switzerland
Facility Name
University of Zurich Hospital
City
Zurich
Country
Switzerland
Facility Name
University Hospitals of Coventry and Warwickshire
City
Coventry
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
West Midlands
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29807890
Citation
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):
Results Reference
derived
PubMed Identifier
29566816
Citation
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.
Results Reference
derived
PubMed Identifier
27282848
Citation
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.
Results Reference
derived
PubMed Identifier
23998714
Citation
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.
Results Reference
derived

Learn more about this trial

Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

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