Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
This study is currently recruiting participants.
Verified January 2012 by Almazov Federal Center of Heart, Blood and Endocrinology
Sponsor:
Almazov Federal Center of Heart, Blood and Endocrinology
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 14, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2013 |
| Estimated Primary Completion Date: | December 2013 (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
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 14, 2012 |
| 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 May 21, 2013