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

Sponsor
AtriCure, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02513797
Collaborator
(none)
600
Enrollment
53
Locations
2
Arms
78
Anticipated Duration (Months)
11.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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. (COMPLETED) All subjects from both stages will be included in the primary analysis.

Condition or Disease Intervention/Treatment Phase
  • Device: LARIAT + PVI
  • Device: Pulmonary Vein Isolation
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Apr 21, 2021
Anticipated Study Completion Date :
Mar 1, 2022

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 Names:
  • 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 [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 [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 [12 months following index pulmonary vein isolation]

    Other Outcome Measures

    1. LARIAT Technical Success [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Arrhythmia Research Center Phoenix Arizona United States 85013
    2 Phoenix Cardiovascular Research Group Phoenix Arizona United States 85018
    3 Scripps Clinic La Jolla California United States 92037
    4 University of California San Diego La Jolla California United States 92037
    5 University of Southern California Los Angeles California United States 90033
    6 University of California San Francisco San Francisco California United States 94143
    7 Santa Barbara Cottage Hospital Santa Barbara California United States 93103
    8 Stanford University Stanford California United States 94305
    9 Yale University School of Medicine New Haven Connecticut United States 06520
    10 St. Vincent's HealthCare Jacksonville Florida United States 32204
    11 Piedmont Athens Regional Cardiology Athens Georgia United States 30606
    12 Emory University Hospital Atlanta Georgia United States 30342
    13 The Queen's Medical Center Honolulu Hawaii United States 96813
    14 Northwestern University / Bluhm Cardiovascular Institute Chicago Illinois United States 60611
    15 Loyola University Center for Heart and Vascular Medicine Maywood Illinois United States 60153
    16 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
    17 Prairie Education and Research Cooperative Springfield Illinois United States 62769
    18 Northwestern Medicine Central DuPage Hospital Winfield Illinois United States 60190
    19 Community Hospital Munster Indiana United States 46321
    20 Iowa Heart Center West Des Moines Iowa United States 50266
    21 University of Kansas Medical Center Research Institute Kansas City Kansas United States 66160
    22 Kansas City Cardiac Arrhythmia Research Overland Park Kansas United States 66215
    23 University of Kentucky Lexington Kentucky United States 40536
    24 Cardiovascular Institute of the South Clinical Research Corporation Houma Louisiana United States 70360
    25 Ochsner Medical Center New Orleans Louisiana United States 70121
    26 Johns Hopkins Baltimore Maryland United States 21287
    27 UP Health System- Marquette Marquette Michigan United States 49855
    28 St. Luke's Hospital Kansas City Missouri United States 64111
    29 DaVita Medical Group Las Vegas Nevada United States 89169
    30 Hackensack University Medical Center Hackensack New Jersey United States 07601
    31 Morristown Medical Center Morristown New Jersey United States 07960
    32 The Valley Hospital Ridgewood New Jersey United States 07450
    33 New Mexico Heart Institute Albuquerque New Mexico United States 87102
    34 Montefiore Medical Center Bronx New York United States 10467
    35 Maimonides Medical Center Brooklyn New York United States 11219
    36 New York University Langone Medical Center New York New York United States 10016
    37 Ohio State University Wexner Medical Center Columbus Ohio United States 43210
    38 The Ohio Health Research Institute Columbus Ohio United States 43214
    39 Southern Oregon Cardiology Medford Oregon United States 97504
    40 Oregon Health & Science University Portland Oregon United States 97239
    41 Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    42 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    43 Trident Medical Center Charleston South Carolina United States 29406
    44 Medical University of South Carolina Charleston South Carolina United States 29466
    45 Vanderbilt University Nashville Tennessee United States 37232
    46 Texas Cardiac Arrhythmia Research Foundation Austin Texas United States 78705
    47 Austin Heart Austin Texas United States 78756
    48 Baylor - St. Luke's Medical Center Houston Texas United States 77030
    49 Houston Methodist Houston Texas United States 77030
    50 Baylor Plano Scott & White Research Institute Heart Hospital Plano Texas United States 75093
    51 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    52 Christus Trinity Mother Frances Health System Tyler Texas United States 75701
    53 Providence Sacred Heart Medical Center Spokane Washington United States 99204

    Sponsors and Collaborators

    • AtriCure, Inc.

    Investigators

    • Study Chair: David J Wilber, MD, Loyola University Department of Medicine
    • Study Chair: Dhanunjaya Lakkireddy, MD, Kansas City Cardiac Arrhythmia Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AtriCure, Inc.
    ClinicalTrials.gov Identifier:
    NCT02513797
    Other Study ID Numbers:
    • RS-011
    • NCT02631915
    First Posted:
    Aug 3, 2015
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Sep 5, 2021