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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01444573
First received: September 29, 2011
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Device: implantable continuous monitor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Hospitalization for all cardio-vascular events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • life-threatening arrhythmic and drugs adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444573

Locations
Russian Federation
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD    +79139254858    E.Pokushalov@gmail.com   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sub-Investigator: Denis Losik         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
  More Information

No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01444573     History of Changes
Other Study ID Numbers: RVL-001-32
Study First Received: September 29, 2011
Last Updated: October 23, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Rate control
ILR

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014