Intracardiac Echocardiography Guided Watchman Device Implant

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06007872
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intracardiac Echocardiography (ICE) — DEVICE
    ICE will be used to guide trans-septal puncture and to guide device implant.

Study Details

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.

Key Dates

Start date
Dec 2, 2022
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Intervention
    Intracardiac Echocardiography (ICE)

Primary Outcome Measure

Successful Watchman implantation using intracardiac echocardiography (ICE) guidance [ Time Frame: During the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Oussama Wazni, MD
[email protected]
216-444-2131
Oussama Wazni, MD, MBA (PRINCIPAL_INVESTIGATOR)
Walid Saliba, MD (SUB_INVESTIGATOR)
Mohamed Kanj, MD (SUB_INVESTIGATOR)
Tyler Taigen, MD (SUB_INVESTIGATOR)
Serge Harb, MD (SUB_INVESTIGATOR)
Rhonda Miyasaka, MD (SUB_INVESTIGATOR)
Samir Kapadia, MD (SUB_INVESTIGATOR)

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