aMAZE Trial Continued Access Protocol

NCT ID: NCT04468334

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2023-04-24

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.

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• 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

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

Group Type: EXPERIMENTAL

LARIAT + PVI

Intervention Type: DEVICE

LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures

Interventions

LARIAT + PVI

LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures

Intervention Type: DEVICE

Other Intervention Names

LAA + RF PVI; LAA + Cryo PVI

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 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

• 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: PRINCIPAL_INVESTIGATOR

Loyola University Department of Medicine

Dhanunjaya Lakkireddy, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City Cardiac Arrhythmia Research

Locations

University of California San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

St. Vincent's HealthCare

Jacksonville, Florida, United States

Emory University Hospital

Atlanta, Georgia, 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

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

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

The Valley Hospital

Ridgewood, New Jersey, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Southern Oregon Cardiology

Medford, Oregon, United States

Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor - St. Luke's Medical Center

Houston, 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)

Other Identifiers

RS-011, Appendix 16

Identifier Type: -

Identifier Source: org_study_id