Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

Meshalkin Research Institute of Pathology of Circulation90 enrolled

Overview

The investigators hypothesized that very lenient rate control is not inferior to strict or lenient rate control assessed by implantable continuous ECG monitor for preventing cardiovascular hospitalization and mortality in patients with long-standing persistent or permanent atrial fibrillation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

implantable continuous monitorDEVICE

The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Long-standing persistent or permanent atrial fibrillation * Mean resting heart rate \> 80 beats per minute with or without rate control medication * Age \< 70 years old * Constant use of anticoagulation therapy Exclusion Criteria: * Paroxysmal or persistent atrial fibrillation * Non-stable heart failure or \> III NYHA FC * Indications for IPG/CRT/ICD * Thyroid dysfunction * Inability to walk or bike.

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

Hospitalization for all cardio-vascular events

Time frame: 12 months

Secondary Outcomes

All-cause death

Time frame: 12 months

stroke

Time frame: 12 months

life-threatening arrhythmic and drugs adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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