Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation
Phase 3
- Conditions
- Atrial Fibrillation
- Interventions
- Device: implantable continuous monitor
- 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
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
- Arm && Interventions
Group Intervention Description Group 2 (Lenient control <120bpm) implantable continuous monitor - Group 1 (Strict control <80 bpm) implantable continuous monitor -
- Primary Outcome Measures
Name Time Method Hospitalization for all cardio-vascular events 12 months
- Secondary Outcome Measures
Name Time Method stroke 12 months life-threatening arrhythmic and drugs adverse events 12 months All-cause death 12 months
Trial Locations
- Locations (1)
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
🇷🇺Novosibirsk, Russian Federation