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

Seoul National University Hospital50 enrolled

Overview

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.

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation (AF)

Interventions

Pacemaker implantation with Left bundle branch area pacing (LBBAP)PROCEDURE

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

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 management

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion: Patients who meet all of the following inclusion criteria 1)-6). 1. Permanent atrial fibrillation 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: Patients who meet at least one of the following exclusion criteria 1)-11). 1. Asymptomatic atrial fibrillation 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

Locations (1)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up

Time frame: 6 months after intervention.

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

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.

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

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'

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

Central Contacts

Eue-keun Choi, M.D. Ph.D

CONTACT

82-2-2072-0688 choiek417@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.