NCT07470047

Accelerated LBBP for Patients With RHF and Severe TR

Accelerated Left Branch Bundle Pacing in the Treatment of Right Heart Failure With Severe Tricuspid Regurgitation: A Prospective, Multicenter, Single-Arm Target Value Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, target value clinical trial. We plan to prospectively enroll and follow 24 patients across three centers nationwide who have a low baseline heart rate (HR ≤ 60 bpm), meet the indication for permanent pacemaker implantation, and have right-sided heart failure with severe or greater tricuspid regurgitation. All patients will undergo pacemaker implantation using left bundle branch pacing (LBBP), and the pacing rate will be uniformly increased to 90 bpm (reduced to 80-85 bpm in case of intolerance). Patients will be followed for 6 months to evaluate the effects of heart-rate increase on hemodynamics, heart failure symptoms, and physical function in patients with right-sided heart failure.

Detailed description

After eligibility screening and written informed consent are obtained, all participants will undergo baseline assessments including vital signs, biochemical tests, New York Heart Association (NYHA) functional class, diuretic index, edema grade, echocardiographic parameters, 6-minute walk distance (6MWD), and the Kansas City Cardiomyopathy Questionnaire (KCCQ). All patients will then receive pacemaker implantation with the lead positioned for left bundle branch pacing to achieve conduction system pacing. The pacing rate will initially be set at 60 bpm, followed by right heart catheterization. Hemodynamic parameters will be recorded during both diastole and systole, including pressures in the superior vena cava, inferior vena cava, right atrium, right ventricle, and pulmonary artery. Mean pressure values will then be calculated, and mean pulmonary capillary wedge pressure and pulmonary vascular resistance will be measured. Cardiac output (CO) will be assessed invasively using a cardiac output monitoring system integrated with the right heart catheterization setup, based on the Fick principle. The pacing rate will then be increased to 90 bpm; after 5 minutes of stabilization, right heart catheterization will be repeated. On the day after pacemaker implantation, transthoracic echocardiography (TTE) will be performed, and relevant parameters will be measured at pacing rates of 60 and 90 bpm. Before discharge, the pacing rate will be set to 90 bpm. Diuretics will be prescribed as clinically indicated, and escalation of diuretic dosage will not be permitted during the follow-up period. Follow-up visits will be scheduled at 1 month, 3 months, and 6 months after discharge. Assessments at each visit will include vital signs, biochemical tests, NYHA functional class, diuretic index, edema grade, KCCQ score, 6MWD, and echocardiographic parameters.

Conditions

• Right Heart Failure

Interventions

Type	Name	Description
PROCEDURE	permanent pacemaker implantation	Implant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm.

Timeline

• Start date: 2026-03-10
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

3 sites across 1 country: China