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

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health1 site in 1 country11 target enrollmentDecember 2010

ConditionsHeart Failure

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Enrollment: 11
Locations: 1
Primary Endpoint: Left Ventricle End-Systolic Volume (LV ESV)
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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)

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

December 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Left Ventricle End-Systolic Volume (LV ESV)

Time Frame: 12 months

Secondary Outcomes

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