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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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19 February 2015 |
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Main ID: |
NCT01164319 |
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Date of registration:
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15/07/2010 |
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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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"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
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Scientific title:
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Typing of the Atrial Fibrillation Recurrences in Early Postoperative Period After Pulmonary Veins Isolation Through Continous Subcutaneous Monitoring. |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01164319 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), 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 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:
- highly symptomatic patients refractory to at least two antiarrhythmic drugs
- patients with sustained PAF episodes and/or history of PersAF interrupted with
cardioversion.
Exclusion Criteria:
- congestive heart failure
- ejection fraction <35%
- left atrial diameter >60 mm
- previous ablation procedure
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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Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation
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Primary Outcome(s)
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Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
[Time Frame: 12 months]
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Secondary Outcome(s)
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Freedom from AF in each group and the comparison of any group to each other
[Time Frame: 12 months]
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Secondary ID(s)
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AFERAWCLP-022
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RU AF 002
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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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