Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation (REVEAL)

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 3

Conditions: Atrial Fibrillation

Treatments: Device: implantable continuous monitor

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01444573

RVL-001-32

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Group 2 (Lenient control <120bpm)

Active Comparator group

Treatment:

Device: implantable continuous monitor

Group 1 (Strict control <80 bpm)

Active Comparator group

Treatment:

Device: implantable continuous monitor