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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.
Full 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.
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Inclusion criteria
Subjects must meet all of the following criteria to be eligible for the study:
Age ≥ 18 years and ≤ 80 years at time of screening.
Documented diagnosis of symptomatic persistent or persistent longstanding non-valvular atrial fibrillation
Note: Persistent AF and Longstanding Persistent AF must be documented as follows:
Persistent AF:
Longstanding Persistent AF:
Failed previous catheter PVI ablation
Life expectancy ≥ 1 year;
Willing and able to return to and comply with scheduled follow-up visits and tests; and
Willing and able to provide written informed consent
Exclusion criteria
Exclusion Criteria: Subjects will be excluded if he / she meets any of the following:
Subjects will also be excluded if they meet any of the following:
Based on screening computed tomography angiography (CTA) performed prior to study intervention:
LAA Morphology: Superior-posterior oriented LAA (i.e. superior C shape), that has:
LAA positioned behind the pulmonary artery; or
All other LAA morphology: LAA LARIAT approach width > 45 mm.
Based on a peri-procedural imaging (TEE at time of hybrid sub-X MAZE procedure. or catheter ablation):
100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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