None listed
Conditions
Interventions
Others(Medical intervention (modification of the pacing rate in a permanent pacemaker)) : Optimized Pacing Strategy
• Definition of Optimal Heart Rate: After permanent pacemaker implantation, hemodyn
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 19 years. 2. Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions: A. Sick sinus syndrome with or without impaired atrioventricular conduction B. Persistent or permanent atrial fibrillation with slow ventricular response C. Chronotropic incompetence 3. Patients diagnosed with heart failure, defined as meeting one of the following criteria: A. Left ventricular ejection fraction < 50% confirmed by transthoracic echocardiography B. 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
Exclusion criteria: 1. 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. 2. 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 3. Patients with contraindications to permanent pacemaker implantation (e.g., life expectancy < 1 year). 4. Patients with moderate or greater valvular stenosis or regurgitation. 5. Patients with dyspnea not attributable to heart failure, due to uncontrolled comorbid conditions (e.g., uncontrolled chronic obstructive pulmonary disease, interstitial lung disease, asthma, etc.). 6. Pregnant or breastfeeding women. 7. Patients who have refused active treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart failure symptom (KCCQ score) | — |
Secondary
| Measure | Time frame |
|---|---|
| NTproBNP;Functional status;Distance in 6-minute walk test;Hospitalization due to heart failure;Occurrence of AF or burden of AF;Invasive hemodynamics parameters in right heart catheterization;all-cause mortality;Echocardiographic parameters;Battery longevity;Re-hospitalization due to any cause;ECG parameters;Average heart rate;Heart rate distribution | — |
Countries
Korea, Republic of
Contacts
Public ContactJuwon Kim
Samsung Medical Center
Outcome results
None listed