IRB Study Number 22-1084
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Left atrial appendage closure 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. This procedure is done with a Transesophageal echocardiogram (TEE), where a camera is placed down the throat and takes ultrasound pictures of the heart.
The objective of this study is to investigate a new work flow that may ultimately demonstrate that the TEE may not be necessary, removing 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.
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. PFO or ASD closure devices in place).
