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

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

Status and phase

Terminated
Phase 4

Conditions

Heart Failure

Treatments

Device: Implantation of CRT device
Device: Implantation of conventional VVI(R) pacemaker

Study type

Interventional

Funder types

Other

Identifiers

NCT01512381
zubarev-vista-17-12

Details and patient eligibility

About

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)

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

CRT
Experimental group
Treatment:
Device: Implantation of CRT device
pacemaker
Active Comparator group
Treatment:
Device: Implantation of conventional VVI(R) pacemaker

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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