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

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ClinicalTrials.gov Identifier: NCT02513797
Recruitment Status : Recruiting
First Posted : August 3, 2015
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: LARIAT + PVI Device: Pulmonary Vein Isolation

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LARIAT + PVI Treatment Group
Percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) with the LARIAT System prior to planned pulmonary vein isolation (PVI) catheter ablation
Device: LARIAT + PVI
Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures
Other Name: Left Atrial Appendage ligation + Pulmonary Vein Isolation
Device: Pulmonary Vein Isolation
Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
Active Comparator: PVI Catheter Ablation Group
Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
Device: Pulmonary Vein Isolation
Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.


Outcome Measures

Primary Outcome Measures :
  1. Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation [ Time Frame: 12 months following Pulmonary Vein Isolation catheter ablation procedure ]
    Measured by 24-hour Holter Monitoring


Secondary Outcome Measures :
  1. Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD [ Time Frame: Following the 90 day blanking period through 12 months post-index pulmonary vein isolation ]
    Measured by 24-hour Holter Monitoring

  2. Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee [ Time Frame: 12 months following index pulmonary vein isolation ]

Other Outcome Measures:
  1. LARIAT Technical Success [ Time Frame: Immediately post-LARIAT ligation (acute) and at 12 months following index pulmonary vein isolation ]
    Successful placement of the LARIAT device pre-tied suture around the left atrial appendage to achieve left atrial appendage ligation defined as ≤1 ± 1mm diameter residual communication w/ left atrium, as assessed by transesophageal echocardiography


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) 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 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. 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 > 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)

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513797


Contacts
Contact: Pamela P Simons, BS, RT 650-241-6011 psimons@sentreheart.com

  Hide Study Locations
Locations
United States, Arizona
Arizona Arrhythmia Research Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Sophie Raymond    602-456-2342    sraymond@azheartrhythm.com   
Principal Investigator: Vijendra Swarup, M.D.         
Phoenix Cardiovascular Research Group Recruiting
Phoenix, Arizona, United States, 85018
Contact: Aneta Scafaru    602-628-8595    Ascafaru@iri-az.com   
Principal Investigator: Marwan Bahu, MD         
United States, California
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Chelsea Butler    858-652-5538    Butler.Chelsea@scrippshealth.org   
Principal Investigator: Douglas Gibson, MD         
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Maylene Alegre    858-246-2406    malegre@ucsd.edu   
Principal Investigator: Jonathan Hsu, M.D.         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Ramos, RN    323-442-7983    Melissa.Ramos@med.usc.edu   
Principal Investigator: Rahul Doshi, M.D.         
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Shabir Sarwary    415-514-8881    Shabir.Sarwary@ucsf.edu   
Principal Investigator: Nitish Badhwar, M.D.         
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93103
Contact: Amy Jenneve    805-569-7461    ajenneve@sbch.org   
Principal Investigator: Brett Gidney, MD, FACC         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Bemen Habashi    203-737-3570    bemen.habashi@yale.edu   
Principal Investigator: James Freeman, M.D. MPH MS         
United States, Florida
St. Vincent's HealthCare Recruiting
Jacksonville, Florida, United States, 32204
Contact: Lisa Joseph    904-308-6405    lisa.joseph@ascension.org   
Principal Investigator: Saumil Oza, M.D.         
United States, Georgia
Athens Regional Cardiology Recruiting
Athens, Georgia, United States, 30606
Contact: Alyssa Smith, RN    706-475-1828    alyssa.smith@athenshealth.org   
Principal Investigator: Kent Nilsson, MD         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Joel Eggebeen, RN, CCRC    404-712-7848    joel.eggebeen@emory.edu   
Contact: Paige Smith    404-686-7992    pfsmith@emory.edu   
Principal Investigator: Michael Hoskins, M.D.         
United States, Illinois
Northwestern University / Bluhm Cardiovascular Institute Recruiting
Chicago, Illinois, United States, 60611
Contact: Amy Carswell    312-926-7554    Amy.carswell@nm.org   
Principal Investigator: Albert C. Lin, M.D.         
Loyola University Center for Heart and Vascular Medicine Recruiting
Maywood, Illinois, United States, 60153
Contact: Nancy Schoenecker    708-216-2646    nschoenecker@luc.edu   
Principal Investigator: David Wilber, M.D.         
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Michelle Nellett, APN    708-684-4522    Michelle.Nellett@advocatehealth.com   
Principal Investigator: William Spear, M.D.         
Northwestern Medicine Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Contact: Seema Jain    630-933-7581    seema.jain@nm.org   
Principal Investigator: Todd Tomson, MD         
United States, Iowa
Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Sara Burg    515-633-3845    scburg@iowaheart.com   
Principal Investigator: Troy Hounshell, D.O.         
United States, Kansas
University of Kansas Medical Center Research Institute Recruiting
Kansas City, Kansas, United States, 66160
Contact: Donita Atkins    816-651-1969    datkins2@kumc.edu   
Principal Investigator: Dhanunjaya Lakkireddy, MD FACC FHRS         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Loney Girod    504-842-8092    loney.girod@ochsner.org   
Principal Investigator: Freddy M Abi-Samra, M.D.         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michele Martucci    410-502-0517    mmill148@jhmi.edu   
Principal Investigator: Ronald Berger, M.D.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Belma Halilovic, RC    617-643-0456    bhalilovic@mgh.harvard.edu   
Principal Investigator: Moussa Mansour, M.D.         
United States, Michigan
UP Health System- Marquette Recruiting
Marquette, Michigan, United States, 49855
Contact: Lori Piggott, R    906-225-7190    lori.piggott@mghs.org   
Principal Investigator: Rudolph Evonich, III, M.D.         
United States, Nevada
DaVita Medical Group Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Carol Wingfield    702-933-9419    CWingfield@hcpnv.com   
Principal Investigator: Erik Sirulnick, M.D.         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Diane Agar, RC    973-971-5951    diane.agar@atlantichealth.org   
Principal Investigator: Timothy Mahoney, MD         
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Selina Diaz    201-447-8453    sdiaz3@valleyhealth.com   
Principal Investigator: Daniel Musat, MD         
Sub-Investigator: Suneet Mittal, MD         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Adriana Flores    505-843-2822    adrianaf@nmhi.com   
Principal Investigator: Michael Bestawros, M.D.         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Amanda O'Malley    518-292-6000    aomalley@capitalcardiology.com   
Principal Investigator: James O'Brien, M.D.         
Southside Hospital / Feinstein Institute for Medical Research Withdrawn
Bay Shore, New York, United States, 11706
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Dalvert Polanco, M.D.    718-920-6442 ext 8576    DAPOLANC@montefiore.org   
Principal Investigator: Luigi DiBiase, M.D.         
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jessica Holzman    212-263-9977    Jessica.Holzman@nyumc.org   
Principal Investigator: Anthony Aizer, M.D.         
Mount Sinai Hospital / Icahn School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Betsy Ellsworth    212-824-8902    betsy.ellsworth@mountsinai.org   
Principal Investigator: Vivek Reddy, M.D.         
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago    516-562-6790    lyn.santiago@chsli.org   
Contact: Joan Jennings    516 562-6790    joan.jennings@chsli.org   
Principal Investigator: Joseph Levine, M.D.         
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Keri Baia    614-685-4621    keri.baia@osumc.edu   
Principal Investigator: John Hummel, M.D.         
The Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Vickie Hatch    614-566-1261    Vickie.Hatch@OhioHealth.com   
Principal Investigator: Sreedhar Billakanty, M.D.         
United States, Oregon
Southern Oregon Cardiology Recruiting
Medford, Oregon, United States, 97504
Contact: Jean Anne Eisenhaure    541-930-7253    eisenhaurej@socardiology.com   
Principal Investigator: Eric Pena, M.D.         
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Liz Cannard    503-494-5893    cannarde@ohsu.edu   
Principal Investigator: Charles Henrikson, M.D.         
United States, Pennsylvania
Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Sheetal Chandhok, M.D.       chandhokmd@yahoo.com   
Principal Investigator: Sheetal Chandhok, MD         
Butler Medical Providers Recruiting
Butler, Pennsylvania, United States, 16001
Contact: Jennie Hunter    724-284-6234    jennie.hunter@butlerhealthsystem.org   
Principal Investigator: David Schwartzman, M.D.         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sarah Herbert, RN, BSN    412-648-6024    herbertsa@upmc.edu   
Principal Investigator: Raveen Bazaz, M.D.         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29466
Contact: Deborah Everidge    843-792-2944    adamsde@musc.edu   
Principal Investigator: Frank Cuoco, M.D.         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Carol Meisch    615-343-4983    carol.meisch@Vanderbilt.edu   
Principal Investigator: Christopher Ellis, M.D.         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal, RN    512-431-4868    dscardinal@austinheartbeat.com   
Principal Investigator: Rodney Horton, M.D.         
Austin Heart Recruiting
Austin, Texas, United States, 78756
Contact: Kevin Bacon    512-421-3877    Kevin.Bacon@hcahealthcare.com   
Principal Investigator: David Tschopp, M.D.         
Baylor - St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Aline Barzilla, CCRC    832-355-3710    abarzilla@bcm.edu   
Principal Investigator: Abdi Rasekh, MD, F.A.C.C.         
Baylor Plano Scott & White Research Institute Heart Hospital Recruiting
Plano, Texas, United States, 75093
Contact: Heath Shirkey    469-814-4185    Heath.Shirkey@BSWHealth.org   
Principal Investigator: Brian Deville, M.D.         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Joan Hecht, RN    210-617-5300 ext 14654    Joan.Hecht@va.gov   
Principal Investigator: Manoj Panday, M.D.         
Christus Trinity Mother Frances Health System Recruiting
Tyler, Texas, United States, 75701
Contact: Carol Cushman    903-606-8846    Carol.Cushman@tmfhc.org   
Principal Investigator: Stanley Weiner, M.D.         
Sponsors and Collaborators
SentreHEART, Inc.
Investigators
Study Chair: David J Wilber, MD Loyola University Department of Medicine
Study Chair: Dhanunjaya Lakkireddy, MD KU Medical Center, University of Kansas
More Information

Additional Information:
Publications:
Responsible Party: SentreHEART, Inc.
ClinicalTrials.gov Identifier: NCT02513797     History of Changes
Obsolete Identifiers: NCT02631915
Other Study ID Numbers: RS-011
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes