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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Implantation of CRT device
Implantation of conventional VVI(R) pacemaker
Sponsored by
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, CRT, atrial fibrillation, AV junction ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Almazov Federal Heart, Blood and Endocrinology Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRT

pacemaker

Arm Description

Outcomes

Primary Outcome Measures

Left Ventricle End-Systolic Volume (LV ESV)

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2012
Last Updated
June 5, 2018
Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT01512381
Brief Title
Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
Acronym
VISTA
Official Title
Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Absence of patients for recruitment
Study Start Date
December 2010 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, CRT, atrial fibrillation, AV junction ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT
Arm Type
Experimental
Arm Title
pacemaker
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Implantation of CRT device
Intervention Description
RV lead of CRT system is implanted into the middle part of interventricular septum
Intervention Type
Device
Intervention Name(s)
Implantation of conventional VVI(R) pacemaker
Intervention Description
RV lead is implanted into the middle part of interventricular septum
Primary Outcome Measure Information:
Title
Left Ventricle End-Systolic Volume (LV ESV)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of cardiovascular events (hospitalization for worsening heart failure)
Time Frame
12 month
Title
Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)
Time Frame
12 months
Title
Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test
Time Frame
12 months
Title
Echocardiographic indexes of LV remodeling
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Almazov Federal Heart, Blood and Endocrinology Centre
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation

12. IPD Sharing Statement

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

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