Status:
RECRUITING
Intracardiac Echocardiography Guided Watchman Device Implant
Lead Sponsor:
The Cleveland Clinic
Conditions:
Atrial Fibrillation
Left Atrial Appendage Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in...
Detailed Description
Left atrial appendage occlusion is approved as an indicated therapy for patients with non valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance of long term use ...
Eligibility Criteria
Inclusion
- All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial
Exclusion
- Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
- Patients receiving a concomitant ablation procedure
- Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
- Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06007872
Start Date
December 2 2022
End Date
December 31 2027
Last Update
October 21 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195