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

The University of Texas Health Science Center, Houston

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Persistent Atrial Fibrillation

Interventions

Catheter ablationPROCEDURE

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 procedurePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of participants who are free from atrial fibrillation (AF)

Time frame: 12 months after the procedure

Secondary Outcomes

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

AF burden will be assessed using the Canadian Cardiovascular Society - Severity of Atrial Fibrillation Score (CCA-SAF), which provides objective symptoms severity scoring.

Time frame: 12 months after the procedure

Data from ClinicalTrials.gov

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