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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using Intracardiac Echocardiography for Watchman Device Implantation

Official title: Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant

Run by The Cleveland Clinic · NCT06007872 · Data updated 2026-11-12

This study is testing if using a special ultrasound method called Intracardiac Echocardiography can make it safer and easier to implant the Watchman device for patients with atrial fibrillation and a high risk of stroke.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorThe Cleveland Clinic
Academic / other
Locations1 site (Cleveland, Ohio)
StatusRecruiting
StartedDecember 2, 2022
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedNovember 9, 2026
Trial IDNCT06007872 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients who meet the established criteria for the Watchman device and are not currently enrolled in another clinical trial.

Probably not a fit

Patients who cannot undergo TEE or require a concomitant ablation procedure may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of Intracardiac Echocardiography (ICE) in guiding the implantation of the Watchman device for patients with non-valvular atrial fibrillation and high stroke risk. Traditionally, Transesophageal Echocardiography (TEE) has been used for this procedure, but it requires general anesthesia and carries risks of injury. The study aims to demonstrate that ICE can be a safe and effective alternative, potentially reducing the need for additional personnel and anesthesia. By comparing ICE to TEE in a larger patient sample, the study seeks to establish a new workflow for the Watchman device implantation.

Why it matters

Potential benefit: If successful, this approach could simplify the implantation process and reduce associated risks for patients.

How similar studies have gone: Smaller studies have suggested that ICE can be effective, but this study aims to provide systematic comparison with TEE in a larger cohort.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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).

Where it's running

  • Cleveland Clinic
    Cleveland, Ohio, United States     Recruiting

Study contacts

  • Principal investigator: Oussama Wazni, MD — The Cleveland Clinic
  • Study coordinator: Oussama Wazni, MD
  • Email: waznio@ccf.org
  • Phone: 216-444-2131

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.