aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation (aMAZE)

Trial Purpose and Description

To demonstrate the ability of the LARIAT+® Suture Delivery System
to: (1) percutaneously isolate and ligate the Left Atrial Appendage
(LAA) from the left atrium (LA) as an adjunct to planned pulmonary
vein isolation (PVI) catheter ablation in the treatment of subjects
with symptomatic persistent or longstanding persistent atrial
fibrillation (AF); (2) demonstrate that the adjunctive percutaneous
LAA ligation procedure does not result in an unacceptable risk of
serious adverse events (SAEs) in persistent or longstanding
persistent AF subjects for whom a catheter ablation procedure is
planned; and (3) assess freedom from episodes of AF > 30 seconds
duration any time following the 90-day blanking period post-index
PVI through 12 months post PVI.

Ages: 18 - 80 years

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Documented diagnosis of symptomatic persistent or longstanding persistent non-valvular atrial fibrillation
  • Failed at least one Class I or III Antiarrythmic drug (AAD)
  • 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:

  • Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesion are suspected;
  • Prior epicardial or endocardial atrial fibrillation ablation procedure;
  • LA diameter > 6 cm as measured by computerized tomography;
  • Documented embolic stroke, transient ischemic attachor suspected neurologic event within 3 months prior to the planned intervention;
  • Currently exhibits New York Heart Association Class IV heart failure symptoms;
  • Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
  • 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;
  • Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
  • 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 of thoracic radiation with the exception of localized radiation treatment for breast cancer;
  • Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
  • Active pericarditis;
  • Active endocarditis;
  • Any documented history or autoimmune disease associated with pericarditis;
  • Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
  • Untreated severe scoliosis (documented and clinically defined by treating physician);
  • Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
  • Documented presence of implanted congenital defect closure devices, (e.g., atrial septal defect, patent foramen ovale or ventricular septal defect device);
  • Previously attempted occlusion of the left atrial appendage (by any surgical or percutaneous method);
  • Body Mass Index (BMI) > 40;
  • Evidence of active Graves disease;

Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging

Subjects will also be excluded if they meet any of the following:

  • Based on screening computed tomography angiography performed within 90 days prior to study intervention as confirmed by the core lab:
    • Left atrial appendage morphology: Superior-posterior oriented left atrial appendage (i.e. superior C shape), that has:
      1. Left atrial appendage LARIAT-approach width ≥ 40 mm; or
      2. Left atrial appendage distal apex extending posterior to the ostium of the appendage.
    • Left atrial appendage positioned behind the pulmonary artery; or
    • All other left atrial morphology: Left atrial appendage LARIAT approach width > 45 mm.
  • Based on a peri-procedural imaging (transesophageal echocardiography) at time of LARIAT or catheter ablation) and confirmed by institution's designated LARIAT echocardiographer:
    • Intracardiac thrombus; or
    • Significant mitral valve stenosis (i.e., mitral valve stenosis < 1.5cm2)

SentreHEART, Inc.

Dates: 10/06/2016 - 10/31/2018

Last Updated: 10/08/2016

Study HIC#: 1606017873

Get Involved

For more information about this study, contact:
Bemen Habashi
+1 203-737-1330
bemen.habashi@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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