Actively Recruiting
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
Led by Samsung Medical Center · Updated on 2026-05-01
106
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure. * Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart rate. * Primary Endpoint: Heart failure symptoms, assessed by the Kansas City Cardiomyopathy Questionnaire score. * Hypothesis: In patients with heart failure requiring permanent pacing, an optimized pacing strategy will lead to a significant improvement in heart failure symptoms (Kansas City Cardiomyopathy Questionnaire score) at 12 months compared with the conventional pacing strategy.
CONDITIONS
Official Title
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic bradycardia who require permanent pacemaker implantation and have one of the following: sick sinus syndrome (with or without impaired atrioventricular conduction), persistent or permanent atrial fibrillation with slow ventricular response, or chronotropic incompetence
- Patients diagnosed with heart failure with left ventricular ejection fraction of 50% or higher on transthoracic echocardiography
- Patients with H2FPEF score of 6 or more or HFA-PEFF score of 5 or more
- Patients with N-terminal pro-B-type natriuretic peptide levels of 300 pg/mL or higher (sinus rhythm) or 600 pg/mL or higher (atrial fibrillation)
- Patients with prior hospitalization for heart failure or documented use of loop diuretics for heart failure symptoms
You will not qualify if you...
- Patients expected to have a ventricular pacing burden of 20% or more without sufficient capture of cardiac physiologic pacing (biventricular pacing, His bundle pacing, or left bundle branch area pacing) defined as paced QRS duration of 140 ms or less
- Patients not expected to achieve sufficient pacing dependency, defined as baseline atrial rate over 60 bpm (sinus rhythm) or baseline ventricular rate over 60 bpm (atrial fibrillation/flutter) on Holter or inpatient ECG monitoring
- Patients with contraindications to permanent pacemaker implantation
- Patients with moderate or greater valvular stenosis or regurgitation
- Patients with dyspnea not caused by heart failure due to uncontrolled other medical conditions
- Pregnant or breastfeeding women
- Patients who have refused active treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Juwon Kim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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