NCT01444573
Unknown
Phase 3
Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation
Meshalkin Research Institute of Pathology of Circulation1 site in 1 country90 target enrollmentSeptember 2011
ConditionsAtrial Fibrillation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Hospitalization for all cardio-vascular events
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Hospitalization for all cardio-vascular events
Time Frame: 12 months
Secondary Outcomes
- All-cause death(12 months)
- stroke(12 months)
- life-threatening arrhythmic and drugs adverse events(12 months)
Study Sites (1)
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