aMAZE Trial Continued Access Protocol
Completed · Not applicable
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT04468334
- Run by
- AtriCure, Inc.
- People needed
- 82
- Starts
- 2020-03-09
- Expected to finish
- 2023-04-24
- Last updated by the study team
- 2024-03-12
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
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.