Accelerated LBBP for Patients With RHF and Severe TR (NCT07470047) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Accelerated LBBP for Patients With RHF and Severe TR
China24 participantsStarted 2026-03-10
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. Mean pulmonary artery pressure (mPAP) \> 35 mmHg measured by right heart catheterization at a pacing rate of 60 bpm.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
An increase of ≥10 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at the 6-month follow-up compared with baseline.
Timeframe: From enrollment to the 6-month follow-up