NCT06061978招募中不适用
Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum Oxygen Consumption (VO2 max) in mL/min/kg.
研究概览
简要总结
The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •1/ Pacemaker implanted patient with LBTP lead and back-up right ventricular lead who subsequently underwent successful atrioventricular node ablation for rapid AF 2) NAV ablation procedure performed less than 15 days ago 3) Age ≥ 18 years 4) Woman of childbearing age with effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and for the duration of the study, and a negative urine pregnancy test by B-HCG at inclusion Or, Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
- •5) Membership of a social security scheme 6) Patient follow-up feasible 7) Patient has read and understood the information leaflet and signed the informed consent form
排除标准
- •Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale < 5).
- •LVEF < 40% at inclusion
- •Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship.
- •Patient participating in another interventional trial
- •Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.
- •Pregnant, parturient or breast-feeding women, or those without proven contraception
研究组 & 干预措施
left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)
Experimental
干预措施: left bundle branch of His pacing (Procedure)
left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)
Experimental
干预措施: right ventricular pacing (Procedure)
right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)
Experimental
结局指标
主要结局
Maximum Oxygen Consumption (VO2 max) in mL/min/kg.
时间窗: 18 months
次要结局
- Determination of NT pro BNP or BNP(18 months)
- walking test distance covered(18 months)
- echography criteria: LVEF (%), indexed left ventricular end-systolic volume (mL/m2), indexed cardiac output (L/min/m2), inter-ventricular asynchrony criteria (aortic pre-ejection time - pulmonary pre-ejection time)(18 months)
- Physical component of quality-of-life scale (SF-36)(18 months)
- Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP(18 months)
研究者
研究点 (1)
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