Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
NCT ID: NCT06699342
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-01-27
2027-12-31
Brief Summary
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Detailed Description
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* Randomization 1:1 fashion A randomly permuted-block randomization list was generated by computer at a central location and was stratified by center.
* Study duration:
1. 6 months (for primary outcome)
2. 24 months (for secondary outcomes)
* Study subjects number: 50 patients (25 patients per group)
* Procedures
* Atrioventricular node ablation after successful left bundle branch area pacing at the same procedure time.
* Left bundle branch area pacing will be performed in all patients (using lumenless or stylet-driven lead, on the operator's discretion)
* Atrioventricular node ablation will be performed using the quadripolar 7-Fr 3.5-mm tip ablation catheter and the use of 8.5-F sheath (SR0 or SL1, St. Jude Medical Inc., St. Paul, MN, USA) depending on the operator's experience, and if not stable or failed, a deflectable sheath (Agilis, Abbott Electrophysiology, Menlo Park, CA, USA) will be used. Repeated ablation procedures will be recommended during follow-up if regression of atrioventricular block has occurred.
* Immediately after implant, devices were programmed to achieve the shortest QRS duration. Unipolar pacing was initially used to determine left bundle branch capture.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LBBAP+AVNA arm
Left bundle branch area pacing combined with atrioventricular node ablation.
Pacemaker implantation with Left bundle branch area pacing (LBBAP)
Left bundle branch pacing is a novel pacing modality that can bypass the pathological or disease-vulnerable region in the cardiac conduction system, to provide physiological pacing modality for patients.
The procedure involves the implantation of a permanent pacemaker with a pacing lead positioned at the left bundle branch area to achieve physiological conduction system pacing. LBBAP-Pacemaker device and leads should be implanted according to the physician's standard practice.
Atrioventricular node ablation (AVNA)
Atrioventricular node ablation uses heat energy, called radiofrequency energy, to destroy the area between the upper and lower heart chambers. This area is called the atrioventricular node.
Control arm
Pharmacologic treatment optimized according to guidelines in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Pharmacologic therapy optimized for Atrial Fibrillation management
Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide, propafenone, dronedarone, amiodarone) along with anticoagulation therapy (e.g., apixaban) as per current clinical guidelines (e.g., ESC 2024 or ACC/AHA/HRS 2023) in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Treatment is tailored based on patient tolerance and clinical efficacy.
Interventions
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Pharmacologic therapy optimized for Atrial Fibrillation management
Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide, propafenone, dronedarone, amiodarone) along with anticoagulation therapy (e.g., apixaban) as per current clinical guidelines (e.g., ESC 2024 or ACC/AHA/HRS 2023) in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Treatment is tailored based on patient tolerance and clinical efficacy.
Pacemaker implantation with Left bundle branch area pacing (LBBAP)
Left bundle branch pacing is a novel pacing modality that can bypass the pathological or disease-vulnerable region in the cardiac conduction system, to provide physiological pacing modality for patients.
The procedure involves the implantation of a permanent pacemaker with a pacing lead positioned at the left bundle branch area to achieve physiological conduction system pacing. LBBAP-Pacemaker device and leads should be implanted according to the physician's standard practice.
Atrioventricular node ablation (AVNA)
Atrioventricular node ablation uses heat energy, called radiofrequency energy, to destroy the area between the upper and lower heart chambers. This area is called the atrioventricular node.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 65 years
3. Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
4. New York Heart Association (NYHA) functional class II- IV
5. LVEF \> 40% (within the past 3 months)
6. Patients with at least one of the following:
1. HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 12 months
2. Elevated NT-proBNP (\>900 pg/ml) in the 30 days prior to enrollment
Exclusion:
Exclusion Criteria
2. Life expectancy to \< 12 months.
3. Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
4. Mechanical tricuspid valve replacement
5. Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis)
6. Obstructive hypertrophic cardiomyopathy
7. Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
8. Acute coronary syndrome or coronary revascularization (CABG or PCI) \<3 months
9. Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
10. Pacemaker/ICD/CRT treatment ongoing, or current pacemaker indication
11. Simultaneous participation in a different randomized clinical trial
65 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Eue-Keun Choi
Professor
Locations
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Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PALLIATE-AF
Identifier Type: -
Identifier Source: org_study_id
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