Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure

Phase 4

Terminated

• Conditions: Heart Failure
• Interventions: Device: Implantation of CRT device; Device: Implantation of conventional VVI(R) pacemaker

• Registration Number: NCT01512381
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-19
• Status Verified: 2017-01
• Primary Completion: 2017-09
• Study Completion: 2017-12
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT	Implantation of CRT device	-
pacemaker	Implantation of conventional VVI(R) pacemaker	-

Primary Outcome Measures

Name	Time	Method
Left Ventricle End-Systolic Volume (LV ESV)	12 months

Secondary Outcome Measures

Name	Time	Method
Echocardiographic indexes of LV remodeling	12 months
Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test	12 months
Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)	12 months
Rate of cardiovascular events (hospitalization for worsening heart failure)	12 month

Trial Locations

Locations (1)

Almazov Federal Heart, Blood and Endocrinology Centre; 🇷🇺 Saint-Petersburg, Russian Federation