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

Not Applicable

Withdrawn

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Catheter ablation; Procedure: Mini-maze surgical procedure

• Registration Number: NCT03446222
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

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

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2017-12
• Status Verified: 2018-02
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Last Update Submitted: 2018-02-20
• Study First Posted: 2018-02-26
• Last Update Posted: 2018-02-26
• Study Completion: 2018-12-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter Ablation	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	Mini-maze surgical procedure	Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.

Primary Outcome Measures

Name	Time	Method
Number of participants who are free from atrial fibrillation (AF)	12 months after the procedure

Secondary Outcome Measures

Name	Time	Method
Number of participants who are at risk of stroke	12 months after the procedure
Number of participants who experienced a procedural complication	2 weeks after the procedure
AF burden as assessed by the CCA-SAF	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.
Number of participants who were hospitalized for cardiovascular events	12 months after the procedure

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States