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

NCT ID: NCT01512381

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRT

Group Type EXPERIMENTAL

Implantation of CRT device

Intervention Type DEVICE

RV lead of CRT system is implanted into the middle part of interventricular septum

pacemaker

Group Type ACTIVE_COMPARATOR

Implantation of conventional VVI(R) pacemaker

Intervention Type DEVICE

RV lead is implanted into the middle part of interventricular septum

Interventions

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Implantation of CRT device

RV lead of CRT system is implanted into the middle part of interventricular septum

Intervention Type DEVICE

Implantation of conventional VVI(R) pacemaker

RV lead is implanted into the middle part of interventricular septum

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Almazov Federal Heart, Blood and Endocrinology Centre

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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zubarev-vista-17-12

Identifier Type: -

Identifier Source: org_study_id

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