Viewing Study NCT06007872



Ignite Creation Date: 2024-05-06 @ 7:25 PM
Last Modification Date: 2024-10-26 @ 3:06 PM
Study NCT ID: NCT06007872
Status: RECRUITING
Last Update Posted: 2023-08-31
First Post: 2023-08-17

Brief Title: Intracardiac Echocardiography Guided Watchman Device Implant
Sponsor: The Cleveland Clinic
Organization: The Cleveland Clinic

Study Overview

Official Title: Feasibility Intracardiac Echocardiography Guided Watchman Device Implant
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None