Back to results"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Circumferential PVI and subcutaneous cardiac monitor implantation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Percutaneous continous monitoring, ablation
Eligibility Criteria
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
Sites / Locations
- State Research Institute of CIrculation Pathology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1 (no early recurrence)
Group 2 (early AF recurrence)
Group 3 (early recurrence-no reablation)
Group 4 (early recurrence-early reablation)
Arm Description
Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period.
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period.
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation.
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 will receive early reablation based on data stored by implanted monitor.
Outcomes
Primary Outcome Measures
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
Secondary Outcome Measures
Freedom from AF in each group and the comparison of any group to each other
Full Information
NCT ID
NCT01164319
First Posted
July 15, 2010
Last Updated
April 23, 2012
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT01164319
Brief Title
"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
Official Title
Typing of the Atrial Fibrillation Recurrences in Early Postoperative Period After Pulmonary Veins Isolation Through Continous Subcutaneous Monitoring.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Percutaneous continous monitoring, ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (no early recurrence)
Arm Type
Active Comparator
Arm Description
Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period.
Arm Title
Group 2 (early AF recurrence)
Arm Type
Active Comparator
Arm Description
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period.
Arm Title
Group 3 (early recurrence-no reablation)
Arm Type
Active Comparator
Arm Description
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation.
Arm Title
Group 4 (early recurrence-early reablation)
Arm Type
Active Comparator
Arm Description
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 will receive early reablation based on data stored by implanted monitor.
Intervention Type
Procedure
Intervention Name(s)
Circumferential PVI and subcutaneous cardiac monitor implantation
Intervention Description
The left atrium (LA) and PVs were explored through a transeptal approach. Real-time 3D LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in one lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. The endpoint of ablation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.
The ICM (Reveal XT, Medtronic Inc) was implanted the day of the ablation procedure or 1 week before.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.
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Freedom from AF in each group and the comparison of any group to each other
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny A Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
21930653
Citation
Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Turov A, Shirokova N, Karaskov A. Use of an implantable monitor to detect arrhythmia recurrences and select patients for early repeat catheter ablation for atrial fibrillation: a pilot study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):823-31. doi: 10.1161/CIRCEP.111.964809. Epub 2011 Sep 19.
Results Reference
result
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"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
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