Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
NCT ID: NCT03446222
Last Updated: 2018-02-26
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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WITHDRAWN
NA
INTERVENTIONAL
2016-06-30
2018-12-18
Brief Summary
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Detailed Description
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Even though, catheter ablation is now being offered for symptomatic persistent AF, recurrence after the index procedure in such a persistent AF substrate is not unusual. Redo-catheter ablation is routinely offered for such patients; however long term success still remains low. Non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. More recently, the Wolf Mini-Maze procedure has been utilized with promising results.
This study proposes to randomize a group of persistent AF patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (LAA) ligation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Catheter Ablation
Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
Catheter ablation
Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
Mini-maze surgical procedure
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
Mini-maze surgical procedure
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
Interventions
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Catheter ablation
Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
Mini-maze surgical procedure
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
Eligibility Criteria
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Inclusion Criteria
* Prior pulmonary vein isolation (PVI)
* CHA2DS2VASC \> 0
* Able to tolerate and compliant with oral anticoagulation with either Warfarin, dabigatran, rivoraxaban or apixiban
Exclusion Criteria
* Prior valvular surgery or valve replacement
* Reversible cause for atrial fibrillation
* Currently on dialysis or renal replacement therapy
* Need for concomitant cardiac surgery
* History of MI or stroke ≤2 months prior to ablation
* Intolerance to oral anticoagulants
* Thrombus in the Left atrial appendage
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Principal Investigators
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Rajesh Venkataraman, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-15-0880
Identifier Type: -
Identifier Source: org_study_id
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