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Intracardiac Echocardiography Guided Watchman Device Implant

RECRUITINGN/ASponsored by The Cleveland Clinic
Actively Recruiting
PhaseN/A
SponsorThe Cleveland Clinic
Started2022-12-02
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06007872

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 patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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).

Conditions3

Atrial FibrillationHeart DiseaseLeft Atrial Appendage Thrombosis

Locations1 site

Cleveland Clinic
Cleveland, Ohio, 44195
Oussama Wazni, MD216-444-2131waznio@ccf.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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