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

Primary Purpose

Persistent Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Catheter ablation
Mini-maze surgical procedure
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Catheter Ablation

Mini-maze surgical procedure

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants who experienced a procedural complication
Number of participants who are at risk of stroke
Number of participants who were hospitalized for cardiovascular events
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.

Full Information

First Posted
February 20, 2018
Last Updated
February 20, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03446222
Brief Title
Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
Acronym
EMMCAF
Official Title
Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 18, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter Ablation
Arm Type
Active Comparator
Arm 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.
Arm Title
Mini-maze surgical procedure
Arm Type
Active Comparator
Arm Description
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Mini-maze surgical procedure
Intervention Description
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
Primary Outcome Measure Information:
Title
Number of participants who are free from atrial fibrillation (AF)
Time Frame
12 months after the procedure
Secondary Outcome Measure Information:
Title
Number of participants who experienced a procedural complication
Time Frame
2 weeks after the procedure
Title
Number of participants who are at risk of stroke
Time Frame
12 months after the procedure
Title
Number of participants who were hospitalized for cardiovascular events
Time Frame
12 months after the procedure
Title
AF burden as assessed by the CCA-SAF
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Venkataraman, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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