Heart FailurePhase 4VISTANCT01512381
Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
A Phase 4 study testing Implantation of CRT device and Implantation of conventional VVI(R) pacemaker in people with Heart Failure, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implantation of CRT device and Implantation of conventional VVI(R) pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2010to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Almazov Federal Heart, Blood and Endocrinology Centre
Saint Petersburg, 197341
About this study
Official title: 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)
- Conditions
- Heart Failure
- Being tested
- Implantation of CRT device, Implantation of conventional VVI(R) pacemaker
- Keywords
- heart failure, CRT, atrial fibrillation, AV junction ablation
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of CRT deviceDevice
RV lead of CRT system is implanted into the middle part of interventricular septum
Implantation of conventional VVI(R) pacemakerDevice
RV lead is implanted into the middle part of interventricular septum
| Study group | Role | What they receive |
|---|---|---|
| CRT | Experimental | Not described Receives: Device: Implantation of CRT device |
| pacemaker | Active comparator | Not described Receives: Device: Implantation of conventional VVI(R) pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricle End-Systolic Volume (LV ESV)
Measured: 12 months
Secondary outcomes (4)
Rate of cardiovascular events (hospitalization for worsening heart failure)
Measured: 12 month
Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)
Measured: 12 months
Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test
Measured: 12 months
Echocardiographic indexes of LV remodeling
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startDec 2010
- Primary completionSep 2017
- Study completionDec 2017
Why it stopped: Absence of patients for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512381
- Sponsor's protocol ID
- zubarev-vista-17-12
- Acronym
- VISTA
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2012
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01512381
- Acronym / sponsor ID
- VISTA / zubarev-vista-17-12
- Conditions
- Heart Failure
- Keywords
- heart failure, CRT, atrial fibrillation, AV junction ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Absence of patients for recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT | Experimental | Device: Implantation of CRT device |
| pacemaker | Active comparator | Device: Implantation of conventional VVI(R) pacemaker |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18-75 years
- CHF II-III NYHA
- Persistent/permanent AF requiring AV node ablation
- LVEF < 45%
- Signed informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of CRT deviceRV lead of CRT system is implanted into the middle part of interventricular septum | Device | CRT |
| Implantation of conventional VVI(R) pacemakerRV lead is implanted into the middle part of interventricular septum | Device | pacemaker |
Primary outcome
Left Ventricle End-Systolic Volume (LV ESV)
Time frame: 12 months
4 secondary outcomes
Rate of cardiovascular events (hospitalization for worsening heart failure)
Time frame: 12 month
Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)
Time frame: 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
Echocardiographic indexes of LV remodeling
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Absence of patients for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantation of CRT device and Implantation of conventional VVI(R) pacemaker in people with Heart Failure, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Absence of patients for recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricle End-Systolic Volume (LV ESV) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.