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)
Kansas City Cardiomyopathy Questionnaire — From enrollment to 1year after the procedure Higher scores indicate better health status and a higher quality of life, score 0 to 100
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.
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