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

NCT02513797 | Unknown DMC

• 1 other identifier: RS-011
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 53

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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 Outcomes (1)

• LARIAT Technical Success

  Immediately post-LARIAT ligation (acute) and at 12 months following index pulmonary vein isolation

Study Arms (2)

LARIAT + PVI Treatment Group

EXPERIMENTAL

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; Device: Pulmonary Vein Isolation

PVI Catheter Ablation Group

ACTIVE COMPARATOR

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

Interventions

LARIAT + PVI DEVICE

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

Also known as: Left Atrial Appendage ligation + Pulmonary Vein Isolation

LARIAT + PVI Treatment Group

Pulmonary Vein Isolation 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.

LARIAT + PVI Treatment Group; PVI Catheter Ablation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (53)

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85013, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93103, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

St. Vincent's HealthCare

Jacksonville, Florida, 32204, United States

Location

Piedmont Athens Regional Cardiology

Athens, Georgia, 30606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30342, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Northwestern University / Bluhm Cardiovascular Institute

Chicago, Illinois, 60611, United States

Location

Loyola University Center for Heart and Vascular Medicine

Maywood, Illinois, 60153, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62769, United States

Location

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

Kansas City Cardiac Arrhythmia Research

Overland Park, Kansas, 66215, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Cardiovascular Institute of the South Clinical Research Corporation

Houma, Louisiana, 70360, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

UP Health System- Marquette

Marquette, Michigan, 49855, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

DaVita Medical Group

Las Vegas, Nevada, 89169, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

The Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Southern Oregon Cardiology

Medford, Oregon, 97504, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29466, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Baylor - St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Baylor Plano Scott & White Research Institute Heart Hospital

Plano, Texas, 75093, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Related Publications (2)

• 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.

  PMID: 26678640 BACKGROUND

• 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.

  PMID: 38563835 DERIVED

Related Links

• aMAZE Trial website

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David J Wilber, MD

  Loyola University Department of Medicine

  STUDY CHAIR

• Dhanunjaya Lakkireddy, MD

  Kansas City Cardiac Arrhythmia Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 3, 2015
• Study Start: September 1, 2015
• Primary Completion: April 21, 2021
• Study Completion: March 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (53)