Intracardiac Echocardiography Guided Watchman Device Implant

This study is looking at how well Intracardiac Echocardiography (ICE) works to guide the placement of a Watchman device. The Watchman device helps prevent strokes in people with atrial fibrillation (an irregular heartbeat) who cannot take blood thinners long-term. Currently, doctors use Transesophageal Echocardiography (TEE) for guidance, which often requires general anesthesia and can have risks. This study aims to show that ICE, which is less invasive, can be just as effective in guiding the Watchman implant. You might be able to join if you meet the standard criteria for a Watchman implant and are not already in another study. The main goal is to see if the Watchman device can be successfully implanted using ICE guidance during the procedure. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 100 participants. It is designed to compare the use of Intracardiac Echocardiography (ICE) guidance during the Watchman device implant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, successful Watchman implantation, is measured during the procedure. No further follow-up duration is specified.

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NCT06007872

Intracardiac Echocardiography Guided Watchman Device Implant

Recruiting
NAAges 18+InterventionalDiagnostic
The Cleveland Clinic
~100 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:Intracardiac Echocardiography (ICE)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful Watchman implantation using intracardiac echocardiography (ICE) guidance
Measured over During the procedure
Atrial Fibrillation
Left Atrial Appendage Thrombosis

NCT06007872

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Oussama Wazni, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

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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).
  • Successful Watchman implantation using intracardiac echocardiography (ICE) guidanceDuring the procedure

    Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)