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

June 5, 2018 updated by: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation, 197341
        • Almazov Federal Heart, Blood and Endocrinology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 14, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zubarev-vista-17-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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