Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation

Overview

This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Detailed Description

Higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed. 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

Interventions

  • 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.
  • Procedure: Mini-maze surgical procedure
    • Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: Mini-maze surgical procedure
    • Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants who are free from atrial fibrillation (AF)
    • Time Frame: 12 months after the procedure

Secondary Measures

  • Number of participants who experienced a procedural complication
    • Time Frame: 2 weeks after the procedure
  • Number of participants who are at risk of stroke
    • Time Frame: 12 months after the procedure
  • Number of participants who were hospitalized for cardiovascular events
    • Time Frame: 12 months after the procedure
  • AF burden as assessed by the CCA-SAF
    • Time Frame: 12 months after the procedure
    • AF burden will be assessed using the Canadian Cardiovascular Society – Severity of Atrial Fibrillation Score (CCA-SAF), which provides objective symptoms severity scoring.

Participating in This Clinical Trial

Inclusion Criteria

  • Persistent symptomatic AF with failure of at least 1 anti-arrhythmic drug – Prior pulmonary vein isolation (PVI) – CHA2DS2VASC > 0 – Able to tolerate and compliant with oral anticoagulation with either Warfarin, dabigatran, rivoraxaban or apixiban Exclusion Criteria:

  • Inability to follow-up as per protocol – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rajesh Venkataraman, MD, Principal Investigator, The University of Texas Health Science Center, Houston

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