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The ICE WATCHMAN Trial

Overview

About this study

The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. By eliminating the need for general anesthesia, we hope to show a reduction in procedural time, decrease use of supplemental invasive procedures (central venous line, invasive arterial pressure monitoring and transesophageal echocardiography) and quicker patient recovery time. This approach can decrease healthcare resource utilization and safely simplify left atrial appendage closure with the WATCHMAN device.

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:

  • Men and women, ≥ 18 years of age.
  • The patients is eligible to undergo WATCHMAN device implant procedure.
  • The patient is eligible for short term anticoagulation therapy.
  • Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s).
  • Ability to give informed consent for the procedure.
  • The patient is able and willing to undergo the procedure under moderate sedation.
  • The patient is able and willing to return for required 45-day TEE.

Exclusion Criteria:

  • Patient has contraindication for short term anticoagulation.
  • The patient has history of a hypercoagulable state per medical record documentation.
  • Pregnancy or planning to get pregnant during the investigation.

Eligibility last updated 9/21/21. 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.

Open for enrollment

Contact information:

Agata Sularz M.B., B.Chir.

(507) 255-9117

Sularz.Agata@mayo.edu

More information

Publications

Publications are currently not available

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