- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01512381
Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure (VISTA)
June 5, 2018 updated by: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Variant of Stimulation in Atrioventricular Node Ablation (VISTA) 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)
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Saint-Petersburg, Russian Federation, 197341
- Almazov Federal Heart, Blood and Endocrinology Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CRT
|
RV lead of CRT system is implanted into the middle part of interventricular septum
|
Active Comparator: pacemaker
|
RV lead is implanted into the middle part of interventricular septum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Left Ventricle End-Systolic Volume (LV ESV)
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of cardiovascular events (hospitalization for worsening heart failure)
Time Frame: 12 month
|
12 month
|
Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)
Time Frame: 12 months
|
12 months
|
Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test
Time Frame: 12 months
|
12 months
|
Echocardiographic indexes of LV remodeling
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2010
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
January 12, 2012
First Submitted That Met QC Criteria
January 14, 2012
First Posted (Estimate)
January 19, 2012
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 5, 2018
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zubarev-vista-17-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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