Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation
NCT ID: NCT01444573
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
90 participants
INTERVENTIONAL
2011-09-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (Strict control <80 bpm)
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.
Group 2 (Lenient control <120bpm)
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Non-stable heart failure or \> III NYHA FC
* Indications for IPG/CRT/ICD
* Thyroid dysfunction
* Inability to walk or bike.
18 Years
70 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Evgeny A Pokushalov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Research Institute of Circulation Pathology
Locations
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State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, , Russia
Countries
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Facility Contacts
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Other Identifiers
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RVL-001-32
Identifier Type: -
Identifier Source: org_study_id
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