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

NCT ID: NCT02513797

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2022-03-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

LARIAT + PVI

Intervention Type: DEVICE

Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures

Pulmonary Vein Isolation

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Pulmonary Vein Isolation

Intervention Type: DEVICE

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.

Interventions

LARIAT + PVI

Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Left Atrial Appendage ligation + Pulmonary Vein Isolation

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Wilber, MD

Role: STUDY_CHAIR

Loyola University Department of Medicine

Dhanunjaya Lakkireddy, MD

Role: STUDY_CHAIR

Kansas City Cardiac Arrhythmia Research

Locations

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

Scripps Clinic

La Jolla, California, United States

University of California San Diego

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Stanford University

Stanford, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

St. Vincent's HealthCare

Jacksonville, Florida, United States

Piedmont Athens Regional Cardiology

Athens, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

Northwestern University / Bluhm Cardiovascular Institute

Chicago, Illinois, United States

Loyola University Center for Heart and Vascular Medicine

Maywood, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States

Community Hospital

Munster, Indiana, United States

Iowa Heart Center

West Des Moines, Iowa, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Kansas City Cardiac Arrhythmia Research

Overland Park, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Cardiovascular Institute of the South Clinical Research Corporation

Houma, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Johns Hopkins

Baltimore, Maryland, United States

UP Health System- Marquette

Marquette, Michigan, United States

St. Luke's Hospital

Kansas City, Missouri, United States

DaVita Medical Group

Las Vegas, Nevada, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Maimonides Medical Center

Brooklyn, New York, United States

New York University Langone Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

The Ohio Health Research Institute

Columbus, Ohio, United States

Southern Oregon Cardiology

Medford, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Trident Medical Center

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Austin Heart

Austin, Texas, United States

Baylor - St. Luke's Medical Center

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

Baylor Plano Scott & White Research Institute Heart Hospital

Plano, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Christus Trinity Mother Frances Health System

Tyler, Texas, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26678640 (View on PubMed)

Lakkireddy DR, Wilber DJ, Mittal S, Tschopp D, Ellis CR, Rasekh A, Hounshell T, Evonich R, Chandhok S, Berger RD, Horton R, Hoskins MH, Calkins H, Yakubov SJ, Simons P, Saville BR, Lee RJ; aMAZE Investigators. Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial. JAMA. 2024 Apr 2;331(13):1099-1108. doi: 10.1001/jama.2024.3026.

Reference Type: DERIVED

PMID: 38563835 (View on PubMed)

Related Links

http://amazetrial.com/

aMAZE Trial website

Other Identifiers

RS-011

Identifier Type: -

Identifier Source: org_study_id

NCT02631915

Identifier Type: -

Identifier Source: nct_alias