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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
permanent pacemaker implantation
Procedure/SurgeryImplant a pacemaker using left bundle branch pacing (LBBP) and set the pacing rate to 90 bpm.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: accelerated left branch bundle pacingExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the 6-month follow-upSecondary outcomes
1
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-up2
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.
Time frame
From enrollment to the 6-month follow-up3
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.
Time frame
From enrollment to the 6-month follow-up4
6-minute walk distance (6MWD) at the 1-, 3-, and 6-month follow-up visits
Time frame
From enrollment to the 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: