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

Heart Failure Clinical Trial

— VISTA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01512381
• Other study ID #: zubarev-vista-17-12
• Status: Terminated
• Phase: Phase 4
• Start date: December 2010
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Device:
• Implantation of CRT device
RV lead of CRT system is implanted into the middle part of interventricular septum
• Implantation of conventional VVI(R) pacemaker
RV lead is implanted into the middle part of interventricular septum

Locations

Country	Name	City	State
Russian Federation	Almazov Federal Heart, Blood and Endocrinology Centre	Saint-Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricle End-Systolic Volume (LV ESV)		12 months
Secondary	Rate of cardiovascular events (hospitalization for worsening heart failure)		12 month
Secondary	Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)		12 months
Secondary	Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test		12 months
Secondary	Echocardiographic indexes of LV remodeling		12 months