Accelerated LBBP for Patients With RHF and Severe TR
ConditionRight Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorShanghai Zhongshan Hospital
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- permanent pacemaker implantation
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov