Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
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 criteria
Qualifiers
Sick sinus syndrome with or without impaired atrioventricular conduction
Persistent or permanent atrial fibrillation with slow ventricular response
Chronotropic incompetence
H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5
Disqualifiers
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.
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
Trial design
Treatments tested in this trial
- Adjustment of the pacemaker/ICDs lower rate limit (LRL)
- Conventional lower rate (60bpm)
Treatment groups
106 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov