Trial Search Results

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

This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

This study will be conducted in two stages:

- Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2)

- Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

AtriCure, Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: LARIAT + PVI
  • Device: Pulmonary Vein Isolation

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Documented diagnosis of symptomatic continuous persistent or longstanding persistent
   non-valvular atrial fibrillation

   - Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible
   and intended for standard of care catheter 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:

   - Prior procedure involving opening of the pericardium or entering the pericardial space
   (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where
   adhesions are suspected;

   - Any prior epicardial ablation or any type of left-sided atrial ablation procedure;

   - LA diameter > 6 cm as measured by computerized tomography and confirmed by the imaging
   core laboratory;

   - Documented embolic stroke, transient ischemic attach or suspected neurologic event
   within 3 months prior to the planned study 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 history of cardiogenic shock, hemodynamic instability or any medical
   condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated
   within 3 months prior to the planned study intervention;

   - 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
   tme of baseline screening;

   - Chronic renal insufficiency defined as eGFR < 30 mL/min/1.73m2 withing 3 months prior
   to planned study intervention;

   - 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 oral 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);

   - Inability, or unwillingness or contraindication to undergo TEE or CTA imaging or
   24-hour Holter monitoring;

   - Body Mass Index (BMI) > 40;

   - Evidence of active Graves disease;

   - 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;

   - 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;

   - 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:

   - 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 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 >
      50 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)

NOTE: It is anticipated that a majority of subjects enrolled in the aMAZE Trial will be
elderly US Medicare beneficiaries. Therefore, the results from the aMAZE Trial are expected
to be generalizable to the Medicare population.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sarah Daadi
650-498-5590
Recruiting