Atrial Fibrillation (AF)PALLIATE-AFNCT06699342
Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
A study testing Pacemaker implantation with Left bundle branch area pacing (LBBAP), Atrioventricular node ablation (AVNA) and Pharmacologic therapy optimized for Atrial Fibrillation management in people with Atrial Fibrillation (AF), run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pacemaker implantation with Left bundle branch area pacing (LBBAP), Atrioventricular node ablation (AVNA) and Pharmacologic therapy optimized for Atrial Fibrillation management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who meet all of the following inclusion criteria 1)-6).
- 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)
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- 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
Who cannot join
- Patients who meet at least one of the following exclusion criteria 1)-11).
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Eue-Keun Choi, M.D. Ph.D., 82-10-4147-7196, choiek417@gmail.com
About this study
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.
Read the detailed description
- Multicenter, randomized, open-label clinical trial
- 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:
- 6 months (for primary outcome)
- 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
- Atrial Fibrillation (AF)
- Being tested
- Pacemaker implantation with Left bundle branch area pacing (LBBAP), Atrioventricular node ablation (AVNA), Pharmacologic therapy optimized for Atrial Fibrillation management
- Keywords
- atrial fibrillation, left bundle branch area pacing, Atrioventricular node ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantation with Left bundle branch area pacing (LBBAP)Procedure or surgery
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)Procedure or surgery
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 optimized for Atrial Fibrillation managementDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| LBBAP+AVNA arm | Experimental | Left bundle branch area pacing combined with atrioventricular node ablation. Receives: Procedure: Pacemaker implantation with Left bundle branch area pacing (LBBAP); Procedure: Atrioventricular node ablation (AVNA) |
| Control arm | Sham comparator | Pharmacologic treatment optimized according to guidelines in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation. Receives: Drug: Pharmacologic therapy optimized for Atrial Fibrillation management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up
Measured: 6 months after intervention.
Secondary outcomes (13)
Change in NT-proBNP concentration (pg/ml) at 12, and 24 months
Measured: 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
The SF-36 is a 36-item questionnaire that measures health-related quality of life across eight domains, including physical functioning, bodily pain, and mental health. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: 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
The EuroQol 5-Dimension Questionnaire (EQ-5D) evaluates health-related quality of life using a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are derived as an index value (range: -0.594 to 1)
The value attached to an EQ-5D profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'
Measured: 6, 12 and 24 months after intervention.
Change in left ventricular ejection fraction (LV-EF, %) at 6, 12, and 24 months
Measured: 6, 12 and 24 months after intervention
Change in left ventricular end-diastolic diameter (LVEDD, mm) at 6, 12, and 24 months
Measured: 6, 12 and 24 months after intervention.
Change in left ventricular end systolic diameter (LVESD, mm) at 6, 12, and 24 months
Measured: 6, 12 and 24 months after intervention.
Change in New York Heart Association (NYHA) functional class at 6, 12, and 24 months
The NYHA functional classification system assesses the severity of heart failure symptoms on a scale from Class I (best) to Class IV (worst). Changes in functional class will be evaluated at 6, 12, and 24 months after the intervention to determine the impact on patients' physical activity and symptom burden.
Measured: 6, 12 and 24 months after intervention.
Change in 6 min walk test at 6, 12, and 24 months
Measured: 6, 12, and 24 months after intervention
Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) score at 6, 12, and 24 months
The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening tool that assesses various cognitive domains, including memory, attention, language, visuospatial skills, and executive function. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is generally considered normal, while lower scores suggest cognitive impairment. Changes in MoCA scores will be evaluated at 6, 12, and 24 months post-intervention.
Measured: 6, 12 and 24 months after intervention.
Procedure-related complications (tamponade, device infection, re-intervention, pneumothorax, vascular complications, others)
Measured: 24 months after intervention.
The all-cause mortality at 24 months
Death from any cause during the 24-month follow-up period.
Measured: 24 months after intervention.
Worsening Heart Failure (HF) at 24 Months
*Worsening HF with or without hospitalization: symptoms, signs, imaging, and analytical criteria that require unplanned medical attention with an increase of diuretic use, intravenous diuretic therapy
Measured: 24 months after intervention.
Composite Outcome: Mortality and worsening heart failure (HF) at 24 months
Participants meeting at least one of the criteria: (a) all-cause mortality, (b) worsening heart failure.
Measured: 24 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start27 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699342
- Sponsor's protocol ID
- PALLIATE-AF
- Acronym
- PALLIATE-AF
- Status last verified
- Aug 2026
- First submitted
- 3 Nov 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06699342
- Acronym / sponsor ID
- PALLIATE-AF / PALLIATE-AF
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, left bundle branch area pacing, Atrioventricular node ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Multicenter, randomized, open-label clinical trial
- 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:
- 6 months (for primary outcome)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBBAP+AVNA arm | Experimental | Procedure: Pacemaker implantation with Left bundle branch area pacing (LBBAP), Procedure: Atrioventricular node ablation (AVNA)Left bundle branch area pacing combined with atrioventricular node ablation. |
| Control arm | Sham comparator | Drug: Pharmacologic therapy optimized for Atrial Fibrillation managementPharmacologic treatment optimized according to guidelines in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Patients who meet all of the following inclusion criteria 1)-6).
- 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
Key exclusion criteria (12 listed)
- Patients who meet at least one of the following exclusion criteria 1)-11).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | LBBAP+AVNA arm |
| 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. | Procedure or surgery | LBBAP+AVNA arm |
| Pharmacologic therapy optimized for Atrial Fibrillation managementPharmacologic 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. | Drug | Control arm |
Primary outcome
Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up
Time frame: 6 months after intervention.
13 secondary outcomes
Change in NT-proBNP concentration (pg/ml) at 12, and 24 months
Time frame: 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
Time frame: 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
Time frame: 6, 12 and 24 months after intervention.
Change in left ventricular ejection fraction (LV-EF, %) at 6, 12, and 24 months
Time frame: 6, 12 and 24 months after intervention
Change in left ventricular end-diastolic diameter (LVEDD, mm) at 6, 12, and 24 months
Time frame: 6, 12 and 24 months after intervention.
Change in left ventricular end systolic diameter (LVESD, mm) at 6, 12, and 24 months
Time frame: 6, 12 and 24 months after intervention.
Change in New York Heart Association (NYHA) functional class at 6, 12, and 24 months
Time frame: 6, 12 and 24 months after intervention.
Change in 6 min walk test at 6, 12, and 24 months
Time frame: 6, 12, and 24 months after intervention
Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) score at 6, 12, and 24 months
Time frame: 6, 12 and 24 months after intervention.
Procedure-related complications (tamponade, device infection, re-intervention, pneumothorax, vascular complications, others)
Time frame: 24 months after intervention.
The all-cause mortality at 24 months
Time frame: 24 months after intervention.
Worsening Heart Failure (HF) at 24 Months
Time frame: 24 months after intervention.
Composite Outcome: Mortality and worsening heart failure (HF) at 24 months
Time frame: 24 months after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implantation with Left bundle branch area pacing (LBBAP), Atrioventricular node ablation (AVNA) and Pharmacologic therapy optimized for Atrial Fibrillation management in people with Atrial Fibrillation (AF), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eue-keun Choi, M.D. Ph.D (82-2-2072-0688, choiek417@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up (time frame: 6 months after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.