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

Primary Purpose

Atrial Fibrillation

Status

Unknown status

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

implantable continuous monitor

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Rate control, ILR

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

State Research Institute of CIrculation Pathology Novosibirsk, Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 2 (Lenient control <120bpm)

Group 1 (Strict control <80 bpm)

Arm Description

Outcomes

Primary Outcome Measures

Hospitalization for all cardio-vascular events

Secondary Outcome Measures

All-cause death

stroke

life-threatening arrhythmic and drugs adverse events

Full Information

NCT ID

NCT01444573

First Posted

September 29, 2011

Last Updated

September 21, 2015

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT01444573

Brief Title

Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

Acronym

REVEAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Rate control, ILR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 2 (Lenient control <120bpm)

Arm Type

Active Comparator

Arm Title

Group 1 (Strict control <80 bpm)

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

implantable continuous monitor

Other Intervention Name(s)

Reveal XT, implantable loop recorder

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hospitalization for all cardio-vascular events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

All-cause death

Time Frame

12 months

Title

stroke

Time Frame

12 months

Title

life-threatening arrhythmic and drugs adverse events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evgeny A Pokushalov, MD, PhD

Organizational Affiliation

State Research Institute of Circulation Pathology

Official's Role

Principal Investigator

Facility Information:

Facility Name

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evgeny Pokushalov, MD, PhD

Phone

+79139254858

E.Pokushalov@gmail.com

First Name & Middle Initial & Last Name & Degree

Evgeny Pokushalov, MD, PhD

First Name & Middle Initial & Last Name & Degree

Alexander Romanov, MD, PhD

First Name & Middle Initial & Last Name & Degree

Denis Losik

12. IPD Sharing Statement

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Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

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