Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation

Prior treatment

• Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft (CABG), heart transplantation, valve surgery) where adhesions are suspected;
• Documented embolic stroke, Transient ischemic attack (TIA) or suspected neurologic event within 3 months prior to the planned intervention;
• Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
• Documented history of unstable angina within 3 months prior to the planned study intervention;
• Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
• Known acquired or inherited propensity for forming blood clots (e.g., malignancy, Factor V leiden mutation) established by prior objective testing;
• Previously attempted occlusion of the LAA (by any surgical or percutaneous method);
• Current enrollment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow up;
• 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 LARIAT-approach width ≥ 40 mm; or
  • LAA distal apex extending posterior to the ostium of the LAA.
  • LAA positioned behind the pulmonary artery; or
  • All other LAA morphology: LAA LARIAT approach width \> 45 mm.

Other illness

• Currently exhibits New York Heart Association (NYHA) Class IV heart failure symptoms;
• Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
• Recent documented history of cardiogenic shock, hemodynamic instability or any medical condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated;
• Documented symptomatic carotid disease, defined as \> 70% stenosis or \> 50% stenosis with symptoms;
• Diagnosed active local or systemic infection, septicemia or fever of unknown origin at time of baseline screening;
• End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
• Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
• Any history or thoracic radiation with the exception of localized radiation treatment for breast cancer;
• Any documented history or autoimmune disease associated with pericarditis;
• Evidence of active Graves disease;
• Mental impairment or other psychiatric conditions which may not allow patient to understand the nature, significance and scope of the study;
• Any other criteria, medical illness or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site Primary Investigator; Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging
  • Subjects will also be excluded if they meet any of the following:

Lab values

• Chronic renal insufficiency defined as estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 within 3 months prior to study treatment;
• Thrombocytopenia (platelet count \< 100 x 109/L) based on most recent pre-procedure assessment within 30 days prior to planned intervention;
• Anemia with hemoglobin concentration of \<8 g/dL based on most recent pre-procedure assessment (within 30 days prior to planned intervention);
• Left Ventricular Ejection Fraction (LVEF) \< 30% within 30 days prior to planned intervention;

Other

• Measured LA diameter \> 6.5 cm;
• Active pericarditis;
• Active endocarditis;
• Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
• Untreated severe scoliosis (documented and clinically defined by treating physician);
• Documented presence of implanted congenital defect closure devices, (e.g., atrial septal device (ASD), patent foramen vale (PFO) or ventricular septal device (VSD) device);
• Inability, unwillingness or contraindication to undergo TEE imaging;
• Body Mass Index (BMI) \> 40;
• Current untreated hypothyroidism;
• Any contraindication to suture, endovascular device, or other minimally invasive techniques including percutaneous, transseptal, and/or sub-xiphoid access.
• Subject is pregnant or plans / desires to get pregnant within next 12 months;
• Based on a peri-procedural imaging (TEE at time of hybrid sub-X MAZE procedure. or catheter ablation):
  • Intracardiac thrombus; or
  • Significant mitral valve stenosis (i.e., mitral valve (MV) stenosis \< 1.5cm2)

• 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
  • 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.)
• 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