Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cardiac resynchronization therapy (CRT) is superior to interventricular right ventricle (RV) septal pacing in respect of reverse remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)

Official Title
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Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Implantation of CRT device
* Device: Implantation of conventional VVI(R) pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-75 years CHF II-III NYHA Persistent/permanent AF requiring AV node ablation LVEF < 45% Signed informed consent Able to complete all testing required by the clinical protocol Exclusion Criteria: Myocardial infarction or stroke less than 3 months prior to randomization Patients who require revascularization, radiofrequency ablation of pulmonary veins and substrate of AF The congenital and acquired heart diseases, LV aneurysm, which requires a surgical correction Active inflammatory and autoimmune diseases of a myocardium The thyrotoxicosis The diseases that limit life expectancy (cancer, tuberculosis, etc.) Contraindications to anticoagulants administration at CHADS2> 2 Uncompliant patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT<br> | Device: Implantation of CRT device<br>* RV lead of CRT system is implanted into the middle part of interventricular septum<br>|
| Active Comparator: pacemaker<br> | Device: Implantation of conventional VVI(R) pacemaker<br>* RV lead is implanted into the middle part of interventricular septum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricle End-Systolic Volume (LV ESV) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cardiovascular events (hospitalization for worsening heart failure) |  | 12 month | 
| Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire) |  | 12 months | 
| Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test |  | 12 months | 
| Echocardiographic indexes of LV remodeling |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, CRT, atrial fibrillation, AV junction ablation