Intracardiac Echocardiography Guided Watchman Device Implant
Recruiting · NCT06007872 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Intracardiac Echocardiography (ICE)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States