Left Bundle Branch Pacing + Coronary Sinus Pacing Versus Left Bundle Branch Pacing Alone for Cardiac Resynchronization Therapy in Patients Eligible for CRT-P A Randomized Crossover Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Compare the effects of the LOT-CRT strategy versus left bundle branch block pacing (LBBAP) alone in each patient, comparing baseline to the end of the study FEVI, quality of life and functional class by NYHA.
研究概览
简要总结
The purpose of this pilot clinical trial is to evaluate whether a novel cardiac resynchronization strategy, called LOT-CRT, is more effective than standard physiological pacing alone (LBBAP) in patients with heart failure.
This is a randomized, single-center, crossover pilot study involving 10 patients. All participants will receive a specialized pacemaker (CRT-P) with leads implanted in two specific areas: the Left Bundle Branch Area (LBBAP) and the Coronary Sinus (CS).
Because of the crossover design, each patient will serve as their own control, receiving two different pacing configurations in a random order: Active Phase (LOT-CRT): Simultaneous pacing of the left bundle branch and the coronary sinus. Control Phase (LBBAP alone): Pacing only the left bundle branch area. Each treatment phase will last 6 months, for a total follow-up of 12 months per patient.
By testing both strategies in the same patient, this study will help clinicians identify the most effective way to restore heart synchrony and improve clinical outcomes in patients with advanced heart failure and conduction delays.
详细描述
This is a single-center, randomized, crossover pilot clinical trial. Each patient will serve as their own control. Following the successful implantation of a device capable of stimulating the LBBAP and the coronary sinus, participants will be randomly assigned to one of two treatment sequences:
Sequence A: LOT-CRT (LBBAP + CS) for 6 months, followed by LBBAP alone Sequence B: LBBAP alone for 6 months, followed by LOT-CRT Each treatment phase will last 6 months, followed by an end-point evaluation and a crossover. Since the hemodynamic effect of electrical stimulation is immediate, no washout period is required between phases.
This study was designed as an exploratory pilot study; therefore, no formal sample size calculation was performed. The number of patients enrolled is considered adequate to assess the feasibility of the procedure, the safety of the crossover design, and to identify preliminary signals of clinical and electrical efficacy.
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
- Double (Participant, Investigator)
盲法说明
Since all patients will have both a coronary sinus electrode and a branch electrode (LBBAP) implanted, the study will be blinded only to the participants and to the investigators responsible for conducting the 6-minute walk test, the echocardiogram, and the NT-proBNP assessment. It will not be blinded to the electrophysiologists due to technical requirements. Additionally, outcome assessors and data analysts will also be blinded to the pacing mode (LBBAP or LOT - CRT). It will be blinded to the investigators and the patients. Outcome assessors and data analysts will also be blinded to the pacing mode (LBBAP or LOT - CRT).
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
- •Age ≥18 years
- •Standard CRT-P indications according to ESC 2021 (EF ≤50%, QRS ≥130 ms, sinus rhythm or controlled AF)
- •NYHA class II-IV
- •Coronary venous anatomy suitable for placement of a coronary sinus electrode.
- •Signed informed consent.
- •Successful implantation of electrodes in the coronary sinus and in the left bundle branch area (LBBAP)
排除标准
- •Concomitant indication for implantation of an implantable cardioverter-defibrillator (ICD) or CRT-D
- •Significant uncorrected valvular disease or scheduled or anticipated cardiac surgery during the study period.
- •Anatomical or technical contraindication for lead implantation in the coronary sinus or for lead implantation in the coronary sinus (such as sinus stenosis, coronary sinus branches unsuitable for cannulation, inability to advance and/or stabilize the lead, among others)
- •Persistent atrial fibrillation with uncontrolled rate
- •Comorbidities that may limit life expectancy to <1 year
- •Participation in another clinical trial that could confound the evaluation of results within the last 6 months.
- •Pregnancy or inadequate contraception
- •In the researcher's opinion, the participant would not comply with the activities and visits outlined in the study protocol
研究组 & 干预措施
Sequence B
LBBAP for 6 months only, followed by LOT-CRT
干预措施: Stimulation of the left bundle branch area (LBBAP) (Device)
Sequence A
LOT-CRT (LBBAP + CS) for 6 months, followed by LBBAP alone
干预措施: Left Bundle Branch Optimized CRT (Device)
Sequence A
LOT-CRT (LBBAP + CS) for 6 months, followed by LBBAP alone
干预措施: Stimulation of the left bundle branch area (LBBAP) (Device)
Sequence B
LBBAP for 6 months only, followed by LOT-CRT
干预措施: Left Bundle Branch Optimized CRT (Device)
结局指标
主要结局
Compare the effects of the LOT-CRT strategy versus left bundle branch block pacing (LBBAP) alone in each patient, comparing baseline to the end of the study FEVI, quality of life and functional class by NYHA.
时间窗: 12 months
Investigators will evaluate the following parameters in each patient: Left ventricular ejection fraction (LVEF) by echocardiography and electrocardiogram; functional capacity (NYHA class) using the 6-minute walk test and symptoms reported by the patient; quality of life (MLHFQ) using the MLHFQ quality of life scale
次要结局
未报告次要终点