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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Adjustment of the pacemaker/ICDs lower rate limit (LRL)
Procedure/SurgeryOptimized Pacing Strategy
Conventional lower rate (60bpm)
Procedure/SurgeryConventional Pacing Strategy
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Optimized pacing strategyExperimental treatment 1 intervention
Group B: Conventional pacing strategyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Kansas City Cardiomyopathy Questionnaire
Higher scores indicate better health status and a higher quality of life, score 0 to 100
Time frame
From enrollment to 1year after the procedureSecondary outcomes
1
NTproBNP
pg/mL (picograms per milliliter)
Time frame
From enrollment to 1year after the procedure2
Functional status (NYHA class)
class I to IV, higher NYHA classes indicate poorer functional status.
Time frame
From enrollment to 1year after the procedure3
Distance in 6-minute walk test
m
Time frame
From enrollment to 1year after the procedure4
Occurrence of atrial fibrillation
Documented incidence of atrial fibrillation on 12-lead ECG
Time frame
From enrollment to 1year after the procedureSponsors and contacts
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Source ClinicalTrials.gov