"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Typing of the Atrial Fibrillation Recurrences in Early Postoperative Period After Pulmonary Veins Isolation Through Continous Subcutaneous Monitoring. |
- Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Freedom from AF in each group and the comparison of any group to each other [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | February 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1 (no early recurrence)
Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period.
|
Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation
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. |
|
Active Comparator: Group 2 (early AF recurrence)
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period.
|
Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation
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. |
|
Active Comparator: Group 3 (early recurrence-no reablation)
Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation.
|
Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation
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. |
|
Active Comparator: Group 4 (early recurrence-early 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.
|
Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation
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. |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Russian Federation | |
| State Research Institute of CIrculation Pathology | |
| Novosibirsk, Russian Federation, 630055 | |
| Principal Investigator: | Evgeny A Pokushalov, MD, PhD | State Research Institute of Circulation Pathology |
More Information
Publications:
| Responsible Party: | Meshalkin Research Institute of Pathology of Circulation |
| ClinicalTrials.gov Identifier: | NCT01164319 History of Changes |
| Other Study ID Numbers: | AFERAWCLP-022, RU AF 002 |
| Study First Received: | July 15, 2010 |
| Last Updated: | April 23, 2012 |
| Health Authority: | Russia: Ethics Committee |
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
|
Atrial fibrillation Percutaneous continous monitoring ablation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Recurrence Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on June 13, 2013