Clinical and Hemodynamic Outcomes of OPTimized PACing StratEgies in Heart Failure Patients With Pacing Indications: Randomized-Controlled Trial (OPTPACE-HF)
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.
• 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