Clinical trial NCT03446222: Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
Official title: Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of participants who are free from atrial fibrillation (AF)
timeFrame: 12 months after the procedure
Secondary outcomes:
measure: Number of participants who experienced a procedural complication
timeFrame: 2 weeks after the procedure
measure: Number of participants who are at risk of stroke
timeFrame: 12 months after the procedure
measure: Number of participants who were hospitalized for cardiovascular events
timeFrame: 12 months after the procedure
measure: AF burden as assessed by the CCA-SAF
timeFrame: 12 months after the procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Rajesh Venkataraman, MD
role: PRINCIPAL_INVESTIGATOR
References: