Right Heart FailureARCPNCT07470047
Accelerated LBBP for Patients With RHF and Severe TR
A study testing permanent pacemaker implantation in people with Right Heart Failure, run by Shanghai Zhongshan Hospital at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Right Heart Failure
- What is being tested?
- permanent pacemaker implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- 10 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
xiaoping peng, MD, +86 18060226078, cdyfypxp@163.com
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
wenzhi pan, MD, +86 13774475922, peden@sina.com
Shanghai Geriatric Medical Center
Shanghai, Shanghai Municipality, 201104
lifan yang, MD, +86 18801784843, yang.lifan@zsgmc.sh.cn
About this study
Official title: 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
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.
Read the 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
- Being tested
- permanent pacemaker implantation
- Keywords
- right heart failure, left branch bundle pacing, tricuspid regurgitation
- Medical subject headings
- Heart Failure, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
permanent pacemaker implantationProcedure or surgery
Implant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm.
| Study group | Role | What they receive |
|---|---|---|
| accelerated left branch bundle pacing | Experimental | Implant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm. Receives: Procedure: permanent pacemaker implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
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. Clinical Summary Score (CSS) scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Measured: From enrollment to the 6-month follow-up
6-minute walk distance (6MWD) at the 1-, 3-, and 6-month follow-up visits
Measured: 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.
Measured: From enrollment to the 6-month follow-up
Diuretic index at the 1-, 3-, and 6-month follow-up visits
Diuretic index 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 index equal 3.
Measured: From enrollment to the 6-month follow-up
Edema index at the 1-, 3-, and 6-month follow-up visits
Measured: From enrollment to the 6-month follow-up
Tricuspid regurgitation severity measured by transthoracic echocardiography at the 1-, 3-, and 6-month follow-up visits.
Measured: From enrollment to the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470047
- Sponsor's protocol ID
- B2026-103
- Acronym
- ARCP
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07470047
- Acronym / sponsor ID
- ARCP / B2026-103
- Conditions
- Right Heart Failure
- Keywords
- right heart failure, left branch bundle pacing, tricuspid regurgitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| accelerated left branch bundle pacing | Experimental | Procedure: permanent pacemaker implantationImplant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| permanent pacemaker implantationImplant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm. | Procedure or surgery | accelerated left branch bundle pacing |
Primary outcome
An increase of ≥10 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at the 6-month follow-up compared with baseline.
Time frame: From enrollment to the 6-month follow-up
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.
8 secondary outcomes
New York Heart Association (NYHA) functional class at the 1-, 3-, and 6-month follow-up visits.
Time frame: 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
Time frame: 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.
Time frame: From enrollment to the 6-month follow-up
6-minute walk distance (6MWD) at the 1-, 3-, and 6-month follow-up visits
Time frame: 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.
Time frame: From enrollment to the 6-month follow-up
Diuretic index at the 1-, 3-, and 6-month follow-up visits
Time frame: From enrollment to the 6-month follow-up
Edema index at the 1-, 3-, and 6-month follow-up visits
Time frame: From enrollment to the 6-month follow-up
Tricuspid regurgitation severity measured by transthoracic echocardiography at the 1-, 3-, and 6-month follow-up visits.
Time frame: From enrollment to the 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing permanent pacemaker implantation in people with Right Heart Failure, run by Shanghai Zhongshan Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wenzhi pan, MD (+86 13774475922, peden@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An increase of ≥10 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at the 6-month follow-up compared with baseline. (time frame: From enrollment to the 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.