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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 October 2015 |
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Main ID: |
NCT01444573 |
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Date of registration:
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29/09/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation
REVEAL |
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Scientific title:
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Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01444573 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Evgeny Pokushalov, MD, PhD |
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Address:
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Telephone:
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+79139254858 |
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Email:
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E.Pokushalov@gmail.com |
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Affiliation:
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Name:
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Evgeny A Pokushalov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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State Research Institute of Circulation Pathology |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Device: implantable continuous monitor
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Primary Outcome(s)
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Hospitalization for all cardio-vascular events
[Time Frame: 12 months]
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Secondary Outcome(s)
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life-threatening arrhythmic and drugs adverse events
[Time Frame: 12 months]
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All-cause death
[Time Frame: 12 months]
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stroke
[Time Frame: 12 months]
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Secondary ID(s)
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RVL-001-32
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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