The goal of this clinical trial is to learn if conduction system pacing works as well as cardiac resynchronization therapy (CRT) post atrioventricular (AV) node ablation in adult patients with symptomatic heart failure and atrial fibrillation that is not suitable for rhythm control.
The main question it aims to answer is:
Is AV node ablation with conduction system pacing noninferior to AV node ablation with CRT for the hierarchical composite outcome of all-cause mortality, heart failure hospitalization or urgent heart failure visit, and meaningful improvement in heart failure-related quality of life?
Participants will undergo:
* An AV node ablation and be randomly assigned to receive either a conduction system pacing or a CRT. * Attend follow-up visits (in clinic or by telephone) at baseline, intervention day, 3-month, 12-month, 24-month, and 36-month after the procedure. * Complete questionnaires about heart failure symptoms and quality of life at baseline, 12 months, and yearly. * Have an echocardiogram, an electrocardiogram, and blood tests at baseline and 1 year * At selected centers: they will be asked to wear a bracelet that measures arterial stiffness for 30 minutes and provide a urine sample at baseline and 1 year.
Age 18 years or above.
Patient is diagnosed with AF and deemed not amenable to rhythm control. This diagnosis of AF will be demonstrated by at least one Electrocardiograph (ECG) showing AF that was performed within one year prior to enrollment.
Has history of stable heart failure (regardless left ventricular ejection fraction) and has a history of at least one HF related hospitalization or emergency room/urgent care visit within 2 years prior to enrollment, despite being on maximally tolerable guideline directed medical therapy.
Willing and capable to provide informed consent.
NYHA functional class IV.
Severe concomitant non-cardiac disease.
Patient who require any cardiac surgical intervention.
Previously implanted pacing devices (pacemaker/ICD/CRT) with ≥40% pacing burden.
Parallel
Conduction System Pacing
Procedure/SurgeryThe implantation of a pacing device with a pacing lead that aims to capture and pace the native conduction system.
Cardiac resynchronization therapy
Procedure/SurgeryThe implantation of a pacing device with a pacing leads that aims to capture and pace both ventricles in a synchronized fashion, to achieve the best possible hemodynamic parameters and synchrony.
The hierarchical composite endpoint of all-cause mortality, HF hospitalization or unplanned/urgent HF visit, and ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition).
Major secondary endpoint: ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition).
Quality of Life Improvement (AFEQT Questionnaire)
The AFEQT is a disease-specific questionnaire that focuses on assessing the impact of AF on a person's QoL. It covers several domains, including symptoms, daily activities, treatment concerns, and treatment satisfaction. The AFEQT provides scores for each domain as well as a total score, allowing for a comprehensive evaluation of the specific aspects affected by AF on an individual's QoL. Scale 0-100, higher scores indicate no limitation or disability.
Quality of Life Improvement (EQ-5D-5L Questionnaire)
The EQ-5D-5L is a questionnaire used to assess health-related QoL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels indicating the level of problems experienced by the individual ( 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems). The EQ-5D-5L also generates a summary index score that represents overall health status based on societal preferences for different health states.
HF Hospitalization or Unplanned/urgent HF Visit
Duration of hospitalization for cardiovascular causes
Tertiary (Exploratory) Endpoint
Clinical heart failure status (New York Heart Association (NYHA) Functional Classification)
Tertiary (Exploratory) Endpoint. NYHA Classification (scale I-IV): Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.
Healthcare costs and cost-effectiveness parameters
Tertiary (Exploratory) Endpoint
NT-proBNP levels
Tertiary (Exploratory) Endpoint
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