Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant
The Cleveland Clinic
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 genera…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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)…
Interventions
- DeviceIntracardiac Echocardiography (ICE)
ICE will be used to guide trans-septal puncture and to guide device implant.
Location
- Cleveland ClinicCleveland, Ohio