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New treatment option for Heart Failure
Official title Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
ClinicalTrials.gov ID: NCT07563153
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
You likely can't join if
- Patients expected to have a ventricular pacing burden ≥ 20% without sufficient capture of cardiac physiologic pacing, which includes biventricular...
- 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
- Patients with contraindications to permanent pacemaker implantation
- Patients with moderate or greater valvular stenosis or regurgitation.
See the full eligibility criteria
- 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
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.