Recruiting

Watchman Device

Sponsor:

The Cleveland Clinic

Code:

NCT06007872

Conditions

Atrial Fibrillation

Left Atrial Appendage Thrombosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intracardiac Echocardiography (ICE)

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Left Atrial Appendage Thrombosis

Study ID

NCT06007872

Start date

Dec 2, 2022

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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).

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Intervention

Intracardiac Echocardiography (ICE)

Interventions

Intracardiac Echocardiography (ICE)

ICE will be used to guide trans-septal puncture and to guide device implant.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Oussama Wazni, MD

216-444-2131waznio@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Oussama Wazni, MD

216-444-2131waznio@ccf.org

Principal Investigator:

Oussama Wazni, MD, MBA

More Information

Sponsor

The Cleveland Clinic

Last update posted

Oct 21, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-10-21.