Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
Recruiting · NCT07563153 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 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:
- 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.
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, Seoul, South Korea