Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Biotronik, Inc.
- Enrollment
- 1680
- Locations
- 118
- Primary Endpoint
- Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)(Study duration from randomization to study exit)
- Number of Subjects With All-cause Mortality(From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years)
- Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)(Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months))
- Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up(Changes between baseline and 6 months)
- New York Heart Association (NYHA) Classification Change(6 months)