aMAZE Trial Continued Access Protocol (aMAZE CAP)

Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: LARIAT + PVI

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Stanford, California, United States, 94305
      • Stanford University
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's HealthCare
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University / Bluhm Cardiovascular Institute
    • Maywood, Illinois, United States, 60153
      • Loyola University Center for Heart and Vascular Medicine
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Springfield, Illinois, United States, 62769
      • Prairie Education And Research Cooperative
    • Winfield, Illinois, United States, 60190
      • Northwestern Medicine Central DuPage Hospital
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute
    • Overland Park, Kansas, United States, 66215
      • Kansas City Cardiac Arrhythmia Research
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South Clinical Research Corporation
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
  • Michigan
    • Marquette, Michigan, United States, 49855
      • UP Health System- Marquette
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Cardiology
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
    • Houston, Texas, United States, 77030
      • Baylor - St. Luke's Medical Center
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation	Measured by 24-hour Holter Monitoring	12 months following Pulmonary Vein Isolation catheter ablation procedure

Secondary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
LARIAT Technical Success	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	Immediately post-LARIAT ligation (acute) and at 12 months following index pulmonary vein isolation

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: David J Wilber, MD, Loyola University Department of Medicine; Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Cardiac Arrhythmia Research

Publications and helpful links

General Publications

• Lee RJ, Lakkireddy D, Mittal S, Ellis C, Connor JT, Saville BR, Wilber D. Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design. Am Heart J. 2015 Dec;170(6):1184-94. doi: 10.1016/j.ahj.2015.09.019. Epub 2015 Oct 3.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Left Atrial Appendage
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RS-011, Appendix 16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes