Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device
NCT ID: NCT05136417
Last Updated: 2024-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-01-04
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE)
100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation.
intra-procedural intracardiac echocardiography (ICE) probe
placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Interventions
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intra-procedural intracardiac echocardiography (ICE) probe
placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Eligibility Criteria
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Inclusion Criteria
* 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 transesophageal echocardiogram (TEE).
Exclusion Criteria
* The patient has history of a hypercoagulable state per medical record documentation.
* Pregnancy or planning to get pregnant during the investigation.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mohamad Adnan Alkhouli
Principal Investigator
Principal Investigators
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Mohamad Adnan Alkhouli, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Pacific Heart Institute
Santa Monica, California, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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21-009613
Identifier Type: -
Identifier Source: org_study_id