Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
研究概览
简要总结
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.
详细描述
There is currently no evidence of the best mode of definitive pacing after TAVI in patients with preserved systolic ventricular function and AV block. Through this study, investigators intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters.
Investigators will include 24 patients without ventricular dysfunction (LVEF> 50%) and with AV block pacing indication after TAVI.
Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional).
PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12)
Clinical, and echocardiographic follow-up will be performed for 1 year.
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
- Double (Participant, 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
- •Successful implantation of TAVI according to VARC-3 criteria.
- •Indication of cardiac pacing due to AV block according to ESC Guidelines.
- •LVEF> 50%.
- •The patient must indicate their acceptance to participate in the study by signing an informed consent document.
排除标准
- •Ventricular dysfunction: LVEF <50%.
- •Transapical TAVI.
- •Participating currently in a clinical investigation that includes an active treatment.
- •Patients with left bundle branch block but without indication of pacing (AV block).
- •Life expectancy <12 months.
研究组 & 干预措施
Conduction system pacing
Lead placed in the His-Purkinje system (His or left bundle branch) in order to achieve QRS shortening and physiologic pacing.
Crossover from physiological pacing to right ventricular pacing will be allowed in case of failed His bundle pacing or left bundle branch pacing.
干预措施: Conduction system pacing (Procedure)
Right ventricular pacing
Lead placed in the right ventricle (conventional pacing).
干预措施: Right ventricular pacing (Procedure)
结局指标
主要结局
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
时间窗: 12 months
Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement \> 1 point in NYHA class or \> 25% increase in the distance covered in the 6-minute walking test.
次要结局
- Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).(30 days; 12 months.)
- Correction of global longitudinal strain(30 days; 12 months)
- Correction of echocardiographic asynchrony: septal flash expressed in mm.(30 days; 12 months.)
- Distance covered in the 6-minute walking test.(30 days; 12 months.)
- Change in NYHA (New York Heart Association) functional class.(30 days; 12 months.)
- Hospitalization due to heart failure.(12 months.)
- QRS duration.(Baseline)
- Change in left ventricular ejection fraction.(12 months.)
- Change in degree of mitral regurgitation.(30 days; 12 months.)
- Change in NTproBNP.(Baseline; 12 months.)
研究者
Josep Lluis Mont Girbau
Head of Arrhythmia Research.
Hospital Clinic of Barcelona