aMAZE Trial Continued Access Protocol

NCT04468334 | Completed DMC FDA Device

• 1 other identifier: RS-011, Appendix 16
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 25

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.

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage

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 (1)

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

Device: LARIAT + PVI

Interventions

LARIAT + PVI DEVICE

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

Also known as: LAA + RF PVI, LAA + Cryo PVI

LARIAT + PVI Treatment 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 (25)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

St. Vincent's HealthCare

Jacksonville, Florida, 32204, United States

Location

Emory University Hospital

Atlanta, Georgia, 30342, 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

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

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

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Southern Oregon Cardiology

Medford, Oregon, 97504, United States

Location

Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Baylor - St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Related 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.

  PMID: 26678640 BACKGROUND

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

  PRINCIPAL INVESTIGATOR

• Dhanunjaya Lakkireddy, MD

  Kansas City Cardiac Arrhythmia Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: March 9, 2020
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: March 12, 2024

Record last verified: 2023-04

Locations

US (25)