Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
Overview
- Phase
- N/A
- Intervention
- Pacemaker implantation with Left bundle branch area pacing (LBBAP)
- Conditions
- Atrial Fibrillation (AF)
- Sponsor
- Seoul National University Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eue-Keun Choi
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
LBBAP+AVNA arm
Left bundle branch area pacing combined with atrioventricular node ablation.
Intervention: Pacemaker implantation with Left bundle branch area pacing (LBBAP)
LBBAP+AVNA arm
Left bundle branch area pacing combined with atrioventricular node ablation.
Intervention: Atrioventricular node ablation (AVNA)
Control arm
Pharmacologic treatment optimized according to guidelines in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Intervention: Pharmacologic therapy optimized for Atrial Fibrillation management
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(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.)
- Change in left ventricular end systolic diameter (LVESD, mm) at 6, 12, and 24 months(6, 12 and 24 months after intervention.)
- Change in 6 min walk test 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.)
- Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) score at 6, 12, and 24 months(6, 12 and 24 months after 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.)
- Worsening Heart Failure (HF) at 24 Months(24 months after intervention.)
- Composite Outcome: Mortality and worsening heart failure (HF) at 24 months(24 months after intervention.)