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

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ClinicalTrials.gov Identifier: NCT01512381
Recruitment Status : Recruiting
First Posted : January 19, 2012
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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)

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
Study Start Date : December 2010
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Left Ventricle End-Systolic Volume (LV ESV) [ Time Frame: 12 months ]

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Responsible Party: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
ClinicalTrials.gov Identifier: NCT01512381     History of Changes
Other Study ID Numbers: zubarev-vista-17-12
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: January 2017

Keywords provided by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health:
heart failure
CRT
atrial fibrillation
AV junction ablation

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