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

Status unconfirmed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID: NCT02513797
Run by: AtriCure, Inc.
People needed: 600
Starts: 2015-09-01
Expected to finish: 2022-03-01
Last updated by the study team: 2021-09-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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;
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;

Where it is running

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
Arizona Arrhythmia Research Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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