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aMAZE CAP: aMAZE Trial Continued Access Protocol

Sponsor
AtriCure, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04468334
Collaborator
(none)
85
Enrollment
25
Locations
1
Arm
59.7
Anticipated Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of additional safety and effectiveness data at existing aMAZE investigational sites.

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

Detailed Description

For consistency, aMAZE CAP primary and secondary safety and efficacy endpoints, eligibility criteria and follow up visit assessments remain unchanged from the current aMAZE Trial investigation (NCT02517397).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
85 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)
Actual Study Start Date :
Mar 9, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2025

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 Subgroup 1: Radiofrequency (RF) PVI catheter ablation treatment (n<65) Subgroup 2: Cryoballoon PVI catheter ablation treatment (n<20)

Device: LARIAT + PVI
LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures
Other Names:
  • LAA + RF PVI
  • LAA + Cryo PVI

    		•

    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 CAP Trial will be elderly US Medicare beneficiaries. Therefore, the results from the aMAZE CAP Trial are expected to be generalizable to the Medicare population

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94143
    2 Stanford University Stanford California United States 94305
    3 St. Vincent's HealthCare Jacksonville Florida United States 32204
    4 Emory University Hospital Atlanta Georgia United States 30342
    5 Northwestern University / Bluhm Cardiovascular Institute Chicago Illinois United States 60611
    6 Loyola University Center for Heart and Vascular Medicine Maywood Illinois United States 60153
    7 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
    8 Prairie Education and Research Cooperative Springfield Illinois United States 62769
    9 Northwestern Medicine Central DuPage Hospital Winfield Illinois United States 60190
    10 Iowa Heart Center West Des Moines Iowa United States 50266
    11 University of Kansas Medical Center Research Institute Kansas City Kansas United States 66160
    12 Kansas City Cardiac Arrhythmia Research Overland Park Kansas United States 66215
    13 Cardiovascular Institute of the South Clinical Research Corporation Houma Louisiana United States 70360
    14 Ochsner Medical Center New Orleans Louisiana United States 70121
    15 Johns Hopkins Baltimore Maryland United States 21287
    16 UP Health System- Marquette Marquette Michigan United States 49855
    17 St. Luke's Hospital Kansas City Missouri United States 64111
    18 The Valley Hospital Ridgewood New Jersey United States 07450
    19 New Mexico Heart Institute Albuquerque New Mexico United States 87102
    20 Southern Oregon Cardiology Medford Oregon United States 97504
    21 Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    22 Vanderbilt University Nashville Tennessee United States 37232
    23 Texas Cardiac Arrhythmia Research Foundation Austin Texas United States 78705
    24 Baylor - St. Luke's Medical Center Houston Texas United States 77030
    25 Providence Sacred Heart Medical Center Spokane Washington United States 99204

    Sponsors and Collaborators

    • AtriCure, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    AtriCure, Inc.
    ClinicalTrials.gov Identifier:
    NCT04468334
    Other Study ID Numbers:
    • RS-011, Appendix 16
    First Posted:
    Jul 13, 2020
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by AtriCure, Inc.
    Left Atrial Appendage
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jul 19, 2022