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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444573
First Posted: September 30, 2011
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01444573     History of Changes
Other Study ID Numbers: RVL-001-32
First Submitted: September 29, 2011
First Posted: September 30, 2011
Last Update Posted: September 23, 2015
Last Verified: September 2015

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