Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
PALLIATE-AF
1 other identifier
interventional
50
1 country
1
Brief Summary
This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2024
CompletedFirst Posted
Study publicly available on registry
November 21, 2024
CompletedStudy Start
First participant enrolled
January 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 18, 2025
May 1, 2025
2.9 years
November 3, 2024
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up
6 months after intervention.
Secondary Outcomes (13)
Change in NT-proBNP concentration (pg/ml) at 12, and 24 months
12 months and 24 months after intervention.
Change in health-related quality of life measured by 36-item short form survey (SF-36) questionnaire at 6, 12, 24 months
6, 12 and 24 months after intervention.
Change in health-related quality of life measured by EuroQol 5-Dimension Questionnaire (EQ-5D) at 6, 12, 24 months
6, 12 and 24 months after intervention.
Change in left ventricular ejection fraction (LV-EF, %) at 6, 12, and 24 months
6, 12 and 24 months after intervention
Change in left ventricular end-diastolic diameter (LVEDD, mm) at 6, 12, and 24 months
6, 12 and 24 months after intervention.
- +8 more secondary outcomes
Study Arms (2)
LBBAP+AVNA arm
EXPERIMENTALLeft bundle branch area pacing combined with atrioventricular node ablation.
Control arm
SHAM COMPARATORPharmacologic treatment optimized according to guidelines in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Interventions
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 uses heat energy, called radiofrequency energy, to destroy the area between the upper and lower heart chambers. This area is called the atrioventricular node.
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.
Eligibility Criteria
You may qualify if:
- Permanent atrial fibrillation
- Age ≥ 65 years
- Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
- New York Heart Association (NYHA) functional class II- IV
- LVEF \> 40% (within the past 3 months)
- Patients with at least one of the following:
- 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
- Elevated NT-proBNP (\>900 pg/ml) in the 30 days prior to enrollment
You may not qualify if:
- Asymptomatic atrial fibrillation
- Life expectancy to \< 12 months.
- Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
- Mechanical tricuspid valve replacement
- Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis)
- Obstructive hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
- Acute coronary syndrome or coronary revascularization (CABG or PCI) \<3 months
- Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
- Pacemaker/ICD/CRT treatment ongoing, or current pacemaker indication
- Simultaneous participation in a different randomized clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 3, 2024
First Posted
November 21, 2024
Study Start
January 27, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 18, 2025
Record last verified: 2025-05