CRD 1064 VERITAS Study

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the Amulet 2 device in patients who have non-valvular AF at increased risk for stroke and systemic embolism and who are suitable for short-term anticoagulation 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:

  • Paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular AF and has not been diagnosed with rheumatic mitral valve disease
  • CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men
  • Able to stop anticoagulation if the LAA is sealed
  • Able to adhere to the protocol defined pharmacologic regimen following Amulet 2 device implant

Exclusion Criteria:

  • Required to take P2Y12 platelet inhibitor beyond 6 months when Amulet 2 LAA Occluder implant procedure would occur
  • Atrial septal defect or patent foramen ovale repair or occluder
  • Implanted with a mechanical valve prosthesis or an inferior vena cava filter
  • Left ventricular ejection fraction ≤30%
  • Underwent prior attempted endocardial, epicardial, or surgical LAA closure or occlusion, defined as deployment of a device or surgical procedure whether successful or unsuccessful
  • Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to Amulet 2 device implant attempt
  • Experienced stroke or transient ischemic attack within 90 days prior to Amulet 2 device implant attempt
  • Underwent catheter ablation for AF or atrial flutter within 60 days prior to Amulet 2 device implant attempt

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/11/2024. Questions regarding updates should be directed to the study team contact.

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., M.B.A.

Contact us for the latest status

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available