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The ICE WATCHMAN Trial

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Mohamad Adnan Alkhouli, M.D.

Abierto para la inscripción

Contact information:

Agata Sularz M.B., B.Chir.

(507) 255-9117

Sularz.Agata@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20525380

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