Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— REVEAL  

Official title:

Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01444573
• Other study ID #: RVL-001-32
• Status: Recruiting
• Phase: Phase 3
• First received: September 29, 2011
• Last updated: September 21, 2015
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• implantable continuous monitor
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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization for all cardio-vascular events		12 months	Yes
Secondary	All-cause death		12 months	Yes
Secondary	stroke		12 months	Yes
Secondary	life-threatening arrhythmic and drugs adverse events		12 months	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site