Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

Phase 3

• Conditions: Atrial Fibrillation

• Registration Number: NCT01444573
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Primary Completion: 2012-12
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospitalization for all cardio-vascular events	12 months

Secondary Outcome Measures

Name	Time	Method
All-cause death	12 months
stroke	12 months
life-threatening arrhythmic and drugs adverse events	12 months

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation; 🇷🇺 Novosibirsk, Russian Federation