Intracardiac Echocardiography Guided Watchman Device Implant

Atrial Fibrillation Clinical Trial

Official title:

Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007872
• Other study ID #: 22-1084
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: Shady Nakhla, MD
• Phone: 216-445-9474
• Email: NAKHLAS[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage Thrombosis
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Watchman implantation using intracardiac echocardiography (ICE) guidance	Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)	During the procedure