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

The University of Texas System (UT)

Status: Withdrawn

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Catheter ablation; Procedure: Mini-maze surgical procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03446222

HSC-MS-15-0880

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Catheter Ablation

Active Comparator group

Description:

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.

Treatment:

Procedure: Catheter ablation

Mini-maze surgical procedure

Active Comparator group

Description:

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

Treatment:

Procedure: Mini-maze surgical procedure