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

Atrial Fibrillation Clinical Trial

— aMAZE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02513797
• Other study ID #: RS-011
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02631915

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: March 2022
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• LARIAT + PVI
Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures
• 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.

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Piedmont Athens Regional Cardiology	Athens	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Johns Hopkins	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Trident Medical Center	Charleston	South Carolina
United States	Northwestern University / Bluhm Cardiovascular Institute	Chicago	Illinois
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	The Ohio Health Research Institute	Columbus	Ohio
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Cardiovascular Institute of the South Clinical Research Corporation	Houma	Louisiana
United States	Baylor - St. Luke's Medical Center	Houston	Texas
United States	Houston Methodist	Houston	Texas
United States	St. Vincent's HealthCare	Jacksonville	Florida
United States	St. Luke's Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center Research Institute	Kansas City	Kansas
United States	Scripps Clinic	La Jolla	California
United States	University of California San Diego	La Jolla	California
United States	DaVita Medical Group	Las Vegas	Nevada
United States	University of Kentucky	Lexington	Kentucky
United States	University of Southern California	Los Angeles	California
United States	UP Health System- Marquette	Marquette	Michigan
United States	Loyola University Center for Heart and Vascular Medicine	Maywood	Illinois
United States	Southern Oregon Cardiology	Medford	Oregon
United States	Morristown Medical Center	Morristown	New Jersey
United States	Community Hospital	Munster	Indiana
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	New York University Langone Medical Center	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Kansas City Cardiac Arrhythmia Research	Overland Park	Kansas
United States	Arizona Arrhythmia Research Center	Phoenix	Arizona
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Baylor Plano Scott & White Research Institute Heart Hospital	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	The Valley Hospital	Ridgewood	New Jersey
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Stanford University	Stanford	California
United States	Christus Trinity Mother Frances Health System	Tyler	Texas
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Northwestern Medicine Central DuPage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee		12 months following index pulmonary vein isolation

External Links

•   aMAZE Trial website