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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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)


Condition Intervention Phase
Heart Failure
Device: Implantation of CRT device
Device: Implantation of conventional VVI(R) pacemaker
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Variant of Stimulation in Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Almazov Federal Center of Heart, Blood and Endocrinology:

Primary Outcome Measures:
  • Left Ventricle End-Systolic Volume (LV ESV) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512381

Locations
Russian Federation
Almazov Federal Heart, Blood and Endocrinology Centre Recruiting
Saint-Petersburg, Russian Federation, 197341
Contact: Dmitry S Lebedev, Prof    +78127023537    lebedevdmitry@mail.ru   
Contact: Evgeny I Zubarev, MD    +78127023537    dr.zubarev@mail.ru   
Principal Investigator: Dmitry S Lebedev, Prof         
Sub-Investigator: Evgeny I Zubarev, MD         
Sub-Investigator: Viktoria K Lebedeva, PhD         
Sponsors and Collaborators
Almazov Federal Center of Heart, Blood and Endocrinology
  More Information

No publications provided

Responsible Party: Almazov Federal Center of Heart, Blood and Endocrinology
ClinicalTrials.gov Identifier: NCT01512381     History of Changes
Other Study ID Numbers: zubarev-vista-17-12
Study First Received: January 12, 2012
Last Updated: January 10, 2014
Health Authority: Russia: Ethics Committee

Keywords provided by Almazov Federal Center of Heart, Blood and Endocrinology:
heart failure
CRT
atrial fibrillation
AV junction ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014