Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1,680
- 试验地点
- 171
- 主要终点
- Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CRT=ON
Cardiac Resynchronization Therapy activated.
干预措施: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) (Device)
CRT=OFF
Cardiac Resynchronization Therapy deactivated.
干预措施: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) (Device)
结局指标
主要结局
Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
时间窗: 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
时间窗: 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.
次要结局
- 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)