Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation (AF)
• Interventions: Procedure: Pacemaker implantation with Left bundle branch area pacing (LBBAP); Drug: Pharmacologic therapy optimized for Atrial Fibrillation management; Procedure: Atrioventricular node ablation (AVNA)

• Registration Number: NCT06699342
• Lead Sponsor: Seoul National University Hospital

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.

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:

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.

Study Timeline

• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Study Start: 2025-01-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LBBAP+AVNA arm	Pacemaker implantation with Left bundle branch area pacing (LBBAP)	Left bundle branch area pacing combined with atrioventricular node ablation.
LBBAP+AVNA arm	Atrioventricular node ablation (AVNA)	Left bundle branch area pacing combined with atrioventricular node ablation.
Control arm	Pharmacologic therapy optimized for Atrial Fibrillation management	Pharmacologic treatment optimized according to guidelines in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.

Primary Outcome Measures

Name	Time	Method
Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up	6 months after intervention.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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'
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.
Change in left ventricular end systolic diameter (LVESD, mm) at 6, 12, and 24 months	6, 12 and 24 months after intervention.
Change in New York Heart Association (NYHA) functional class at 6, 12, and 24 months	6, 12 and 24 months after intervention.	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.
Change in 6 min walk test at 6, 12, and 24 months	6, 12, and 24 months after intervention
Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) score at 6, 12, and 24 months	6, 12 and 24 months after intervention.	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.
Procedure-related complications (tamponade, device infection, re-intervention, pneumothorax, vascular complications, others)	24 months after intervention.
The all-cause mortality at 24 months	24 months after intervention.	Death from any cause during the 24-month follow-up period.
Worsening Heart Failure (HF) at 24 Months	24 months after intervention.	\*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
Composite Outcome: Mortality and worsening heart failure (HF) at 24 months	24 months after intervention.	Participants meeting at least one of the criteria: (a) all-cause mortality, (b) worsening heart failure.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of