Intracardiac Echocardiography Guided Watchman Device Implant

NCT ID: NCT06007872

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2027-12-31

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.

Detailed Description

Left atrial appendage occlusion is approved as an indicated therapy for patients with non valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance of long term use of oral anticoagulants.

Concurrent procedural TEE is an integral part of the procedure. It is used to guide trans-septal puncture, device sizing and assessment of final adequacy of device implant.

TEE requires the participation and guidance of a cardiac imager and because the TEE probe is in place for a relatively long duration the procedure, the procedure is most commonly performed under general anesthesia. Furthermore TEE can be associated with risk of injury to the oropharynx and esophagus. Our ongoing clinical experience and known literature suggest that TEE may not be necessary for the overall success of the procedure. The objective of the study is to investigate a new work flow that may ultimately demonstrate that intra-procedural TEE may not be necessary, obviating the need for additional personnel, general anesthesia and decreasing overall risk. ICE has been widely used to aid trans-septal puncture and visualize left atrial anatomy. Smaller studies and case series have reported the use of ICE as an alternative to TEE in guiding Watchman device implant. This has not been compared systematically with TEE in a large patient sample.

Conditions

Atrial Fibrillation; Left Atrial Appendage Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention

Intracardiac Echocardiography (ICE)

Group Type: EXPERIMENTAL

Intracardiac Echocardiography (ICE)

Intervention Type: DEVICE

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

Interventions

Intracardiac Echocardiography (ICE)

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

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Oussama Wazni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oussama Wazni, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Oussama Wazni, MD

Role: CONTACT

waznio@ccf.org

216-444-2131

Facility Contacts

Oussama Wazni, MD

Role: primary

waznio@ccf.org

216-444-2131

Other Identifiers

22-1084

Identifier Type: -

Identifier Source: org_study_id