Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation
NCT ID: NCT02562391
Last Updated: 2015-09-29
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
PHASE2
180 participants
INTERVENTIONAL
2011-05-31
2017-05-31
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
DOUBLE
Study Groups
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PVI+Box lesions
Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.
Surgical ablation of the left atrium (PVI+Box lesions)
PVI+Box lesions+LAA cutting
Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.The left atrial appendage was removed by stapling and then cutting.
Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting
Interventions
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Surgical ablation of the left atrium (PVI+Box lesions)
Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting
Eligibility Criteria
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Inclusion Criteria
* Signed inform consent
Exclusion Criteria
* Contraindications for surgical ablation
* Unwilling to participate
18 Years
80 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Locations
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Federal Center of Cardiovascular surgery
Krasnoyarsk, , Russia
Federal State Institution Clinical Hospital of the Presidental Administration of the RF
Moscow, , Russia
Scientific center of the cardiovascular surgery named by A.N. Bakulev
Moscow, , Russia
State Research Institute of CIrculation Pathology
Novosibirsk, , Russia
Countries
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References
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Romanov A, Pokushalov E, Elesin D, Bogachev-Prokophiev A, Ponomarev D, Losik D, Bayramova S, Strelnikov A, Shabanov V, Pidanov O, Kropotkin E, Ivanickii E, Karaskov A, Steinberg JS. Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation. Heart Rhythm. 2016 Sep;13(9):1803-9. doi: 10.1016/j.hrthm.2016.05.012. Epub 2016 May 12.
Other Identifiers
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9872TLAA
Identifier Type: -
Identifier Source: org_study_id
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