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

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 Overview

• Status: Withdrawn
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation; Procedure: Mini-maze surgical procedure

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: Mini-maze surgical procedure; Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.	Procedure: Mini-maze surgical procedure; Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who experienced a procedural complication		2 weeks after the procedure
Number of participants who are at risk of stroke		12 months after the procedure
Number of participants who were hospitalized for cardiovascular events		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.	12 months after the procedure

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Rajesh Venkataraman, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 18, 2018

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HSC-MS-15-0880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO