Accelerated LBBP for Patients With RHF and Severe TR

NCT07470047 | Not Yet Recruiting

• 1 other identifier: B2026-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Right Heart Failure

Keywords

right heart failure, left branch bundle pacing, tricuspid regurgitation

Outcome Measures

Primary Outcomes (1)

• An increase of ≥10 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at the 6-month follow-up compared with baseline.

  Measured as score (score on scale; range 0-100). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. Lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

  From enrollment to the 6-month follow-up

Secondary Outcomes (8)

• New York Heart Association (NYHA) functional class at the 1-, 3-, and 6-month follow-up visits.

  From enrollment to the 6-month follow-up

• The Kansas City Cardiomyopathy Questionnaire (KCCQ) score at the 1-, 3-, and 6-month follow-up visits

  From enrollment to the 6-month follow-up

• The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at the 1-, 3-, and 6-month follow-up visits.

  From enrollment to the 6-month follow-up

• 6-minute walk distance (6MWD) at the 1-, 3-, and 6-month follow-up visits

  From enrollment to the 6-month follow-up

• N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration at the 1-, 3-, and 6-month follow-up visits.

  From enrollment to the 6-month follow-up

Study Arms (1)

accelerated left branch bundle pacing

EXPERIMENTAL

Implant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm.

Procedure: permanent pacemaker implantation

Interventions

permanent pacemaker implantation PROCEDURE

Implant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm.

accelerated left branch bundle pacing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mean resting heart rate ≤ 65 beats/min (based on a resting electrocardiogram).
• Clinically confirmed right-sided heart failure, requiring ≥2 diuretic units to fully control edema, or having persistent grade ≥1 edema despite diuretic therapy.
• Diuretic unit definition: expressed as the number of daily doses at the standard oral dose. For example, the standard units for furosemide, torasemide, and spironolactone are 20 mg/day, 10 mg/day, and 20 mg/day, respectively. If a patient takes furosemide 20 mg twice daily and spironolactone 20 mg once daily, the total diuretic units equal 3.
• Echocardiography shows severe or greater tricuspid regurgitation.
• With/without an indication for permanent pacemaker implantation.
• Is able to understand the purpose of the trial, voluntarily participates and signs written informed consent, and is willing to complete follow-up visits as required by the protocol.

You may not qualify if:

• Mean pulmonary artery pressure (mPAP) \> 35 mmHg measured by right heart catheterization at a pacing rate of 60 bpm.
• Left ventricular ejection fraction (LVEF) \< 50% or left ventricular end-diastolic diameter (LVEDD) \> 56 mm as measured by echocardiography.
• Prior implantation of a cardiac pacemaker.
• Moderate or greater left-sided valvular regurgitation or stenosis.
• Current use of heart rate-lowering medications, such as beta-blockers, digoxin, ivabradine, etc.
• Untreated hypothyroidism.
• Participation in another drug or medical device clinical trial that has not yet been completed.
• Deemed unsuitable for participation in this clinical trial by the investigator.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (3)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Geriatric Medical Center

Shanghai, Shanghai Municipality, 201104, China

Location

MeSH Terms

Conditions

Heart Failure; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Central Study Contacts

wenzhi pan, MD

CONTACT

+86 13774475922; peden@sina.com

junbo ge, MD

CONTACT

+86 13901977506; ge.junbo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will undergo pacemaker implantation, with the atrial lead positioned in the right atrial appendage and the ventricular lead placed in the interventricular septum to achieve left bundle branch pacing (LBBP). Right heart catheterization will be performed in the same session 5 minutes after pacemaker implantation. Before discharge, the pacing rate will be increased to 90 bpm (adjusted to 80-85 bpm in case of intolerance) and maintained until the 6-month follow-up.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 13, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)