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

This study is currently recruiting participants.
Verified January 2014 by Almazov Federal Center of Heart, Blood and Endocrinology
Sponsor:
Information provided by (Responsible Party):
Almazov Federal Center of Heart, Blood and Endocrinology
ClinicalTrials.gov Identifier:
NCT01512381
First received: January 12, 2012
Last updated: January 10, 2014
Last verified: January 2014

January 12, 2012
January 10, 2014
December 2010
December 2014   (final data collection date for primary outcome measure)
Left Ventricle End-Systolic Volume (LV ESV) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01512381 on ClinicalTrials.gov Archive Site
  • Rate of cardiovascular events (hospitalization for worsening heart failure) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Echocardiographic indexes of LV remodeling [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
Variant of Stimulation in Atrioventricular Node Ablation 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)

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
  • Device: Implantation of CRT device
    RV lead of CRT system is implanted into the middle part of interventricular septum
  • Device: Implantation of conventional VVI(R) pacemaker
    RV lead is implanted into the middle part of interventricular septum
  • Experimental: CRT
    Intervention: Device: Implantation of CRT device
  • Active Comparator: pacemaker
    Intervention: Device: Implantation of conventional VVI(R) pacemaker
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Not Provided
Russian Federation
 
NCT01512381
zubarev-vista-17-12
No
Almazov Federal Center of Heart, Blood and Endocrinology
Almazov Federal Center of Heart, Blood and Endocrinology
Not Provided
Not Provided
Almazov Federal Center of Heart, Blood and Endocrinology
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP