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



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:3/23/2019
Start Date:September 2015
End Date:December 2019
Contact:Pamela P Simons, BS, RT
Email:psimons@sentreheart.com
Phone:650-241-6011

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Left Atrial Appendage Ligation With the LARIAT™ Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation 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. (ENROLLING)
All subjects from both stages will be included in the primary analysis.


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 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;

- 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;

- Body Mass Index (BMI) > 40. Investigator may petition for independent adjudication
based on subject body habitus;

- 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.
We found this trial at
55
sites
Morristown, New Jersey 07962
Principal Investigator: Timothy Mahoney, MD
Phone: 973-971-5951
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Moussa Mansour, M.D.
Phone: 617-643-0456
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Luigi DiBiase, M.D.
Phone: 718-920-6442
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Rahul Doshi, M.D.
Phone: 323-442-7983
University of Southern California The University of Southern California is one of the world’s leading...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Charles Henrikson, M.D.
Phone: 503-494-5893
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Manoj Panday, M.D.
Phone: 210-617-5300
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Albany, New York 12208
Principal Investigator: James O'Brien, M.D.
Phone: 518-292-6000
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Albuquerque, New Mexico 87102
Principal Investigator: Michael Bestawros, M.D.
Phone: 505-843-2804
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Athens, Georgia 30606
Principal Investigator: Kent Nilsson, MD
Phone: 706-475-1828
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: David DeLurgio, M.D.
Phone: 404-712-7848
Emory University Hospital As the largest health care system in Georgia and the only health...
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Austin, Texas 78756
Principal Investigator: David Tschopp, M.D.
Phone: 512-421-3877
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Austin, Texas 78758
Principal Investigator: Rodney Horton, M.D.
Phone: 512-431-4868
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Ronald Berger, M.D.
Phone: 410-502-0517
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301 East Main Street
Bay Shore, New York 11706
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Felix Yang, MD
Phone: 718-283-7064
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Bryn Mawr, Pennsylvania 19010
Principal Investigator: Sheetal Chandhok, MD
Phone: 215-313-0742
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1 Hospital Way
Butler, Pennsylvania 16001
Principal Investigator: David Schwartzman, M.D.
Phone: 724-284-6234
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Frank Cuoco, M.D.
Phone: 843-792-2944
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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9300 Medical Plaza Drive
Charleston, South Carolina 29406
Principal Investigator: Frank Cuoco, MD
Phone: 843-847-5025
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Chicago, Illinois 60611
Principal Investigator: Albert C. Lin, M.D.
Phone: 312-926-7554
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: John Hummel, M.D.
Phone: 614-685-4621
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Columbus, Ohio 43214
Principal Investigator: Sreedhar Billakanty, M.D.
Phone: 614-566-1261
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Houma, Louisiana 70360
Principal Investigator: Peter Fail, M.D.
Phone: 985-873-5613
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Houston, Texas 77030
Principal Investigator: Abdi Rasekh, MD, F.A.C.C.
Phone: 713-798-1037
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Houston, Texas 77030
Principal Investigator: Miguel Valderrabano, MD
Phone: 346-238-0290
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Jacksonville, Florida 32204
Principal Investigator: Saumil Oza, M.D.
Phone: 904-308-6405
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Principal Investigator: Madhu Reddy, M.D.
Phone: 913-945-6443
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Kansas City, Missouri 64111
Principal Investigator: Alan Wimmer, M.D.
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Jonathan Hsu, M.D.
Phone: 858-246-2402
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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10666 N Torrey Pines Rd
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1750 East Desert Inn Road
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Lexington, Kentucky
859) 257-9000
Principal Investigator: John C Gurley, M.D.
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Marquette, Michigan 49855
Principal Investigator: Rudolph Evonich, III, M.D.
Phone: 906-225-4658
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Maywood, Illinois 60153
Principal Investigator: David Wilber, M.D.
Phone: 708-216-2646
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Medford, Oregon 97504
Principal Investigator: Eric Pena, M.D.
Phone: 541-930-7253
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Munster, Indiana 46321
Principal Investigator: William Spear, M.D.
Phone: 219-703-1152
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Christopher Ellis, M.D.
Phone: 615-343-4983
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: James Freeman, M.D. MPH MS
Phone: 203-737-3570
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Freddy M Abi-Samra, M.D.
Phone: 504-703-2962
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10029
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Phone: 212-824-8902
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Anthony Aizer, M.D.
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: William Spear, M.D.
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Advocate Christ Medical Center Advocate Health Care, named among the nation
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Overland Park, Kansas 66215
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Phoenix, Arizona 85006
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Phoenix, Arizona
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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1100 Allied Drive
Plano, Texas 75093
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
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Phone: 201-447-8453
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Roslyn, New York 11576
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Phone: 516-562-6790
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San Francisco, California 94143
Principal Investigator: Edward Gerstenfeld, M.D.
Phone: 415-502-3803
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Santa Barbara, California 93105
Principal Investigator: Brett Gidney, MD, FACC
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450 Serra Mall
Stanford, California 94305
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Phone: 650-498-5590
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800 East Dawson Street
Tyler, Texas 75701
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Phone: 903-606-8846
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West Des Moines, Iowa 50266
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Winfield, Illinois 60190
Principal Investigator: Todd Tomson, MD
Phone: 630-933-7581
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