NCT07563153 Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
| NCT ID | NCT07563153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2025-12-18 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07563153 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563153 currently recruiting?
Yes, NCT07563153 is actively recruiting participants. Contact the research team at abcd186a@naver.com for enrollment information.
Where is the NCT07563153 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07563153 clinical trial?
NCT07563153 is sponsored by Samsung Medical Center. The trial plans to enroll 106 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.