Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
Clinical and Hemodynamic Outcomes of OPTimized PACing StratEgies in Heart Failure Patients With Pacing Indications: Randomized-Controlled Trial (OPTPACE-HF)
Samsung Medical Center
106 participants
Dec 18, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions:
- Sick sinus syndrome with or without impaired atrioventricular conduction
- Persistent or permanent atrial fibrillation with slow ventricular response
- Chronotropic incompetence
- Patients diagnosed with heart failure with left ventricular ejection fraction ≥ 50% on transthoracic echocardiography with at least one of the following:
- H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5
- N-terminal pro-B-type natriuretic peptide ≥ 300 pg/mL (sinus rhythm) or ≥ 600 pg/mL (atrial fibrillation)
- Prior hospitalization for heart failure or documented use of loop diuretics for heart failure symptoms
Exclusion Criteria10
- Patients expected to have a ventricular pacing burden ≥ 20% without sufficient capture of cardiac physiologic pacing, which includes biventricular pacing, His bundle pacing, and left bundle branch area pacing.
- (Sufficient cardiac physiologic pacing is defined as a paced QRS duration ≤ 140 ms.)
- Patients not expected to achieve sufficient pacing dependency, defined as:
- In sinus rhythm: baseline atrial rate > 60 bpm on Holter monitoring or inpatient ECG monitoring
- In atrial fibrillation/flutter: baseline ventricular rate > 60 bpm on Holter monitoring or inpatient ECG monitoring
- Patients with contraindications to permanent pacemaker implantation
- Patients with moderate or greater valvular stenosis or regurgitation.
- Patients with dyspnea not attributable to heart failure, due to uncontrolled comorbid conditions
- Pregnant or breastfeeding women.
- Patients who have refused active treatment.
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Interventions
Optimized Pacing Strategy
Conventional Pacing Strategy
Locations(1)
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NCT07563153