The ICE WATCHMAN Trial
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-009613
NCT ID: NCT04569734
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.
More information
Publications
Publications are currently not available