Atrial Fibrillation Clinical Trial
Official title:
Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant
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 patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful Watchman implantation using intracardiac echocardiography (ICE) guidance | Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE) | During the procedure |
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