A Trial Comparing Left Atrial Appendage Occlusion Therapy to Non-Vitamin K Oral Anticoagulants in Atrial Fibrilation Patients

Overview

About this study

The objective of this trial is to evaluate the safety and effectiveness of the Amulet device compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:  

  • Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must  include an electrocardiogram, Holter, or event recorder).
  • At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 3.
  • Eligible for long-term NOAC therapy.
  • Able to comply with the required NOAC medication regimen if randomized to the Control  Group.
  • Able to comply with the required medication regimen post-device implant if subject is  randomized to the Device Group or subject is a Roll-in.
  • Able to understand, and is willing to provide, written informed consent to participate  in the trial, prior to any clinical investigation related procedure or assessment.
  • 18 years of age or older, or the age of legal consent.
  • Able and willing to return for required follow-up visits and assessments.

Exclusion Criteria:  

  • Requires long-term OAC therapy for a condition other than AF.
  • Planned cardiac procedure, which is invasive or requires sedation or anesthesia, within 3 months of randomization (other than study-related procedures such as LAAO and  cardiac imaging (if applicable)).
  • Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use.
  • Indicated for chronic P2Y12 platelet inhibitor.
  • In the opinion of the investigator, is considered at high risk for general anesthesia  and general anesthesia is planned for the study procedure.
  • Has undergone atrial septal defect (ASD) repair or has an ASD closure device present.
  • Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted.
  • Is implanted with a mechanical valve prosthesis  -Is implanted with an inferior vena cava filter.
  • History of rheumatic or congenital mitral valve heart disease.
  • Has any of the customary contraindications for a percutaneous catheterization  procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has active infection or bleeding disorder).
  • Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer).
  • Experienced stroke or transient ischemic attack (TIA) within 90 days prior to  randomization or implant procedure (as applicable).
  • Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to  randomization, or intervention or surgery (e.g., cardioversion, ablation, cataract surgery, etc.) is planned within 60 days after randomization.
  • Experienced myocardial infarction within 90 days prior to randomization.
  • New York Heart Association Class IV Congestive Heart Failure.
  • Left ventricular ejection fraction ≤ 30% (per most recent assessment).
  • Symptomatic carotid disease (defined as > 50% lumen diameter narrowing on CTA, MRA, or  TCD with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax,  ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of  carotid stent or endarterectomy the subject is eligible if there is < 50% lumen  diameter narrowing.
  • Has known intracranial atherosclerosis and/or intracranial small vessel disease  (defined as 6 points on the Fazekas Scale).
  • Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol  intoxication, trauma, recent major surgical procedures).
  • History of idiopathic or recurrent venous thromboembolism.
  • LAA is obliterated or surgically ligated.
  • Thrombocytopenia or anemia requiring transfusions.
  • Hypersensitivity to any portion of the device material or individual components of the  Amulet LAA occluder device (e.g., nickel allergy).
  • Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the  active treatment arm may confound the results of this trial.
  • Is pregnant or breastfeeding, or pregnancy is planned during the course of the  investigation.
  • Active endocarditis or other infection producing bacteremia.
  • Transient case of AF (i.e., never previously detected, provoked/induced by surgical or  catheter manipulations, etc.).
  • Severe renal failure (estimated glomerular filtration rate < 30 ml/min/1.73m^2), but not  on dialysis.
  • Life expectancy is less than 2 years in the opinion of the Investigator.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or  psychological conditions that, in the Investigator's opinion, could limit the  subject's ability to participate in the clinical investigation or to comply with  follow up requirements, or impact the scientific soundness of the clinical  investigation results.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mohamad Adnan Alkhouli, M.D.

Contact us for the latest status

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available