Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

This study has been terminated.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00683696
First received: August 30, 2007
Last updated: March 12, 2014
Last verified: March 2014

August 30, 2007
March 12, 2014
August 2008
March 2013   (final data collection date for primary outcome measure)
  • Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death [ Time Frame: First event from randomization to study exit. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.
  • 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: Full study duration (event driven trial). Minimum 1 year follow-up and expected median patient follow-up duration of 2 years. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00683696 on ClinicalTrials.gov Archive Site
  • Rate of Worsening Heart Failure Hospitalization (Hospitalizations Per Subject-year) [ Time Frame: Study duration from randomization to study exit ] [ Designated as safety issue: No ]
    Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
  • NYHA Classification Change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.
  • Change in Quality of Life Scores From Baseline to 6-Month Follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.
  • Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life [ Time Frame: Study duration from randomization to study exit for death, 24 months for hospitalization, 6 months for QOL evaluation ] [ Designated as safety issue: No ]
    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.
  • Number of Subjects With All-cause Mortality [ Time Frame: Study duration from randomization to study exit ] [ Designated as safety issue: No ]
    Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
  • Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure. [ Time Frame: Full study duration ] [ Designated as safety issue: No ]
  • Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in the Minnesota Living with Heart Failure (MLHF) Quality of Life Questionnaire. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 years for death or hospitalization, 6 months for QOL evaluation ] [ Designated as safety issue: No ]
  • Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group. [ Time Frame: Full study duration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Ventricular Dyssynchrony
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF.
Other Name: Lumax HF-T CRT-D system
  • Experimental: CRT=ON
    Cardiac Resynchronization Therapy activated.
    Intervention: Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
  • Active Comparator: CRT=OFF
    Cardiac Resynchronization Therapy deactivated.
    Intervention: Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1680
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Israel,   Italy,   Netherlands,   Poland,   Portugal,   Spain,   Switzerland,   United Kingdom
 
NCT00683696
EchoCRT
Yes
Biotronik, Inc.
Biotronik, Inc.
University of Zurich
Study Chair: Frank Ruschitzka, MD University of Zurich, Switzerland
Study Chair: Johannes Holzmeister, MD University of Zurich, Switzerland
Principal Investigator: William Abraham, MD Principal Investigator (USA) at The Ohio State University, OH, USA
Principal Investigator: Jagmeet Singh, MD Principal Investigator (USA) at Massachusetts General Hospital, MA, USA
Biotronik, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP