Heart Failure
Conditions
Keywords
heart failure, CRT, atrial fibrillation, AV junction ablation
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)
Interventions
DEVICEImplantation of CRT device
RV lead of CRT system is implanted into the middle part of interventricular septum
DEVICEImplantation of conventional VVI(R) pacemaker
RV lead is implanted into the middle part of interventricular septum
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricle End-Systolic Volume (LV ESV) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Russia
Outcome results
None listed