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NCT07470047Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
24 (estimated)
First submitted
2 Mar 2026
Start date
10 Mar 2026
Primary completion date
31 Dec 2027
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT07470047

What you commit to

  • Study type: Interventional
  • Planned participants: 24
  • From 10 Mar 2026 to the primary completion date, 31 Dec 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior implantation of a cardiac pacemaker.
  • Participation in another drug or medical device clinical trial that has not yet been completed.

Other illness

  • Mean pulmonary artery pressure (mPAP) \> 35 mmHg measured by right heart catheterization at a pacing rate of 60 bpm.
  • Current use of heart rate-lowering medications, such as beta-blockers, digoxin, ivabradine, etc.

Lab values

  • Left ventricular ejection fraction (LVEF) \< 50% or left ventricular end-diastolic diameter (LVEDD) \> 56 mm as measured by echocardiography.

Other

  • Moderate or greater left-sided valvular regurgitation or stenosis.
  • Untreated hypothyroidism.
  • Deemed unsuitable for participation in this clinical trial by the investigator.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of NanChang University
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Shanghai Geriatric Medical Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanghai Zhongshan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.