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

Persistent Atrial Fibrillation Clinical Trial

— EMMCAF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03446222
• Other study ID #: HSC-MS-15-0880
• Status: Withdrawn
• Phase: N/A
• First received: February 20, 2018
• Last updated: February 20, 2018
• Start date: June 2016
• Est. completion date: December 18, 2018

Study information

• Verified date: February 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 18, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who are free from atrial fibrillation (AF)		12 months after the procedure
Secondary	Number of participants who experienced a procedural complication		2 weeks after the procedure
Secondary	Number of participants who are at risk of stroke		12 months after the procedure
Secondary	Number of participants who were hospitalized for cardiovascular events		12 months after the procedure
Secondary	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