Atrial Fibrillation, Persistent
Conditions
Keywords
hybrid, LAA ligation
Brief 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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
Subjects must meet all of the following criteria to be eligible for the study: 1. Age ≥ 18 years and ≤ 80 years at time of screening. 2. Documented diagnosis of symptomatic persistent or persistent longstanding non-valvular atrial fibrillation * Persistent AF is defined as atrial fibrillation sustained for ≥ 7 days and ≤ 1 year; * Longstanding persistent AF is defined as continuous atrial fibrillation \> 1 year duration; * Non-valvular atrial fibrillation is defined as cases without a mechanical heart valve requiring anticoagulation or without moderate to severe mitral stenosis. Note: Persistent AF and Longstanding Persistent AF must be documented as follows: Persistent AF: * Physician's note indicating that patient has experienced symptomatic continuous AF that is sustained ≥ 7 days duration and \< 1 year and clinical history of non-paroxysmal AF \< 3 years; and * A ≥7-day continuous rhythm monitoring (e.g., Zio patch, implantable loop recorder (ILR), pacemaker) which documents 90% AF burden over at least 7 consecutive days or alternatively, two electrocardiograms from any form of rhythm monitoring (e.g. 12-lead ECG, Holter, event monitor) documenting continuous AF, with electrocardiograms taken at least 7 days apart, for subjects with sustained AF ≥ 7 days, as confirmed by the ECG Core Laboratory, obtained within 90 days prior to randomization. Longstanding Persistent AF: * Physician's note indicating that patient has experienced symptomatic continuous AF that is sustained \> 1 year duration and clinical history of non-paroxysmal AF \< 3 years; and * A ≥7-day continuous rhythm monitoring (e.g., Zio patch, ILR, pacemaker) which documents 90% AF burden over at least 7 consecutive days or alternatively, 24 hour continuous rhythm monitoring (e.g. holter, event monitor) obtained within 90 days prior to the index procedure showing continuous AF, as confirmed by the ECG Core Laboratory. Note: The performance of a successful cardioversion (sinus rhythm ≥30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF within 30 days should not alter the classification of AF as Longstanding Persistent.) 3. Failed previous catheter PVI ablation 4. Life expectancy ≥ 1 year; 5. Willing and able to return to and comply with scheduled follow-up visits and tests; and 6. Willing and able to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from episodes of AF > 30 seconds | 12 months | * No evidence of any episode of AF/AT/AFL \> 30 seconds duration, as documented by 24 hour holter monitoring at any time following the 90-day blanking period post index PVI at 6 and 12 months; and/or if patient has symptoms of palpitations. * No additional catheter ablation procedures post index PVI (aside from ablation for right-sided AFL) * No requirement for new Class I or III anti-arrhythmic drug (AAD) prescribed to treat atrial fibrillation following day 120 (90 day blanking period + 30 day window). |
| The incidence of adjudicated significant device- or procedure-related SAEs • Pericardial effusions requiring surgical intervention occurring within 30 days after the hybrid sub-X MAZE procedure. | 30 days after hybrid procedure• Pneumothorax requiring surgical treatment • Vascular Injury requiring surgical treatment | • Serious injury to cardiac/ related structure requiring surgical intervention• Bleeding• Pericarditis requiring surgical treatment• Hemothorax requiring surgical treatment |
Contacts
University of California, San Francisco