Study Stopped
Absence of patients for recruitment
Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
VISTA
Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
1 other identifier
interventional
11
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
Started Dec 2010
Longer than P75 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 12, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 6, 2018
January 1, 2017
6.8 years
January 12, 2012
June 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left Ventricle End-Systolic Volume (LV ESV)
12 months
Secondary Outcomes (4)
Rate of cardiovascular events (hospitalization for worsening heart failure)
12 month
Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)
12 months
Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test
12 months
Echocardiographic indexes of LV remodeling
12 months
Study Arms (2)
CRT
EXPERIMENTALpacemaker
ACTIVE COMPARATORInterventions
RV lead of CRT system is implanted into the middle part of interventricular septum
RV lead is implanted into the middle part of interventricular septum
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Almazov Federal Heart, Blood and Endocrinology Centre
Saint Petersburg, 197341, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2012
First Posted
January 19, 2012
Study Start
December 1, 2010
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
June 6, 2018
Record last verified: 2017-01