Clinical Prospective Randomized Trial to Evaluate the Non-inferiority of Left Bundle Branch Area Pacing vs Cardiac Resynchronization Therapy With ECG Guided AV Optimization (DA VINCI STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- CRT response
研究概览
简要总结
Cardiac resynchronization therapy is the gold standard therapy for patients with advanced HF left ventricle dysfunction and large QRS.
Recently left bundle branch area pacing (LBBAP) or left bundle optimized cardiac resynchronization therapy has been proposed as a rescue therapy for failed or unsuccessful CRT. LBBAP has been also proposed as a physiological pacing modality for patient who need permanent ventricular pacing as an alternative to conventional right ventricular pacing.
Several observational studies have demonstrated the feasibility of this technique due to an ease procedure, stable and appropriate electrical measurements and clinical benefit in terms of patients outcomes.
Furthermore, It is well known that an optimized AV delay (AVD) can improve clinical outcomes preserving a physiological diastolic function.
In clinical practice several different AVD optimization methods have been developed in the last few years.
The majority of them use the intracardiac electrograms during the implant procedure to evaluate QRS duration and AV delay or at follow-up through echocardiographic measurements.
Aim of our pilot project is to assess the non-inferiority of Left Bundle Branch Area Pacing vs Cardiac Resynchronization Therapy with ECG/Echo guided AV optimization.
详细描述
Cardiac resynchronization therapy is the gold standard therapy for patients with advanced HF left ventricle dysfunction and large QRS.
Recently left bundle branch area pacing (LBBAP) or left bundle optimized cardiac resynchronization therapy has been proposed as a rescue therapy for failed or unsuccessful CRT. LBBAP has been also proposed as a physiological pacing modality for patient who need permanent ventricular pacing as an alternative to conventional right ventricular pacing.
Several observational studies have demonstrated the feasibility of this technique due to an ease procedure, stable and appropriate electrical measurements and clinical benefit in terms of patients outcomes.
Furthermore, LBBAP provides a fast activation of the left ventricle and has shown to maintain electrical synchrony shortening the QRS and providing the correction of left bundle branch block (LBBB) by pacing beyond the block.
Despite of that, it is common to find right bundle branch block (RBBB) at the electrocardiography (ECG) that represents a delay in the RV activation and interventricular dissynchrony.
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
- None
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
- •Patients with indications of cardiac resynchronization therapy
- •Patients with Left Branch Block (LBBB) (2021 ESC/REVERSE. Glickson et al _EHJ 2021):
- •Patients over 18 years of age.
排除标准
- •• Women who are pregnant, lactating, or plan to become pregnant during the trial.
- •3rd degree AV Block
- •Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months.
- •Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
- •Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
- •Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
- •Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
- •Expected to receive left ventricular assist device or heart transplantation within 6 months.
- •Participants with severe valvular disease (e.g., aortic stenosis).
- •Have a life expectancy of less than 12 months.
- •Participants with irreversible brain damage from preexisting cerebral disease.
- •Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
- •Long-lasting or permanent atrial fibrillation
- •Participants participating in any other interventional cardiovascular clinical trial.
- •Participants who would be unable to return for follow-up visits due to the distance from the clinic.
- •Participants who do not anticipate being a resident of the area for the scheduled duration of the trial.
结局指标
主要结局
CRT response
时间窗: 6 months
CRT RESPONSE WILL BE DEFINED: * Freedom from HF Hospitalizations * Freedom from Cardiac Death * Reverse remodeling: ≥15% relative reduction in left ventricular end-systolic volume
次要结局
未报告次要终点
研究者
Leonardo Calò, MD
Prof.
Policlinico Casilino ASL RMB