Suspended

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

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What is being tested

Catheter ablation

+ Mini-maze surgical procedure

Procedure
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2016
See protocol details

Summary

Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2016

Actual date on which the first participant was enrolled.

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

Official TitleEpicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
NCT03446222
Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The University of Texas Health Science Center at Houston

Houston, United StatesOpen The University of Texas Health Science Center at Houston in Google Maps
SuspendedOne Study Center