NCT04148625

Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation

Subxyphoid Epicardial/Endocardial Hybrid Atrial Fibrillation Ablation and Left Atrial Appendage (LAA) Exclusion Approach for Patients With Persistent and Longstanding Persistent Atrial Fibrillation Registry

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

Minimally invasive surgical procedures have been advocated as an alternative to catheter ablation for the treatment of persistent atrial fibrillation. Initial results have been promising in maintaining sinus rhythm compared to catheter ablation, but are associated with a considerably greater number of procedural-related adverse events compared to catheter ablation. This study investigates the safety and feasibility of a new subxyphoid epicardial/endocardial hybrid atrial fibrillation ablation and LAA exclusion approach for patients with persistent and longstanding persistent atrial fibrillation.

Detailed description

The study will assess the ability of a subxyphoid and percutaneous hybrid epicardial/endocardial ablation approach consisting of pulmonary vein isolation (PVI), LAA exclusion, isolation of the left atrial (LA) posterior wall and cavotricuspid isthmus (CTI) line (Hybrid Sub-X MAZE) to (1) demonstrate that the hybrid procedure does not result in an unacceptable risk of serious adverse events (SAEs) in persistent or longstanding persistent atrial fibrillation (AF) subjects for whom an ablation procedure is planned; and (2) assess freedom from episodes of persistent AF \> 30 seconds duration during the observation period through 12 months post PVI.

Conditions

• Atrial Fibrillation, Persistent

Timeline

• Start date: 2016-09-14
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2019-11-01
• Last updated: 2026-04-13