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

NCT03446222 | Withdrawn

• 1 other identifier: HSC-MS-15-0880
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  12 months after the procedure

Secondary Outcomes (4)

• 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

  12 months after the procedure

Study Arms (2)

Catheter Ablation

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.

Procedure: Catheter ablation

Mini-maze surgical procedure

ACTIVE COMPARATOR

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

Procedure: Mini-maze surgical procedure

Interventions

Catheter ablation PROCEDURE

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.

Catheter Ablation

Mini-maze surgical procedure PROCEDURE

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

Mini-maze surgical procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Rajesh Venkataraman, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 18, 2018
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)