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Clinical Trials in South Korea / NCT07563153
Recruiting Not applicable

Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker

NCT07563153 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2025-12-18
Last updated
2026-05-01

Condition(s) studied

Heart FailureBradycardia

Investigational drug(s) / intervention(s)

Adjustment of the pacemaker/ICDs lower rate limit (LRL)Conventional lower rate (60bpm)

Adjustment of the pacemaker/ICDs lower rate limit (LRL): Optimized Pacing Strategy

Conventional lower rate (60bpm): Conventional Pacing Strategy

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions: 1. Sick sinus syndrome with or without impaired atrioventricular conduction 2. Persistent or permanent atrial fibrillation with slow ventricular response 3. 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 Criteria: * 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: 1. In sinus rhythm: baseline atrial rate \> 60 bpm on Holter monitoring or inpatient ECG monitoring 2. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul Seoul Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563153 on ClinicalTrials.gov ↗ ← All trials in South Korea