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aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
Recruiting
I'm InterestedTrial ID: NCT02513797
Purpose
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.
Official Title
Left Atrial Appendage Ligation With the LARIAT™ Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation
Stanford Investigator(s)
Nitish Badhwar
Clinical Professor, Medicine - Cardiovascular Medicine
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 within 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.
Intervention(s):
device: LARIAT + PVI
device: Pulmonary Vein Isolation
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sarah Daadi
650-498-5590