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

September 21, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 2 (Lenient control <120bpm)
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.
Other Names:
  • Reveal XT
  • implantable loop recorder
Active Comparator: Group 1 (Strict control <80 bpm)
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.
Other Names:
  • Reveal XT
  • implantable loop recorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospitalization for all cardio-vascular events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
stroke
Time Frame: 12 months
12 months
All-cause death
Time Frame: 12 months
12 months
life-threatening arrhythmic and drugs adverse events
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVL-001-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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