Using Intracardiac Echocardiography for Watchman Device Implantation
Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant
This study is testing if using a special ultrasound method called Intracardiac Echocardiography can make it safer and easier to implant the Watchman device for patients with atrial fibrillation and a high risk of stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06007872 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Intracardiac Echocardiography (ICE) in guiding the implantation of the Watchman device for patients with non-valvular atrial fibrillation and high stroke risk. Traditionally, Transesophageal Echocardiography (TEE) has been used for this procedure, but it requires general anesthesia and carries risks of injury. The study aims to demonstrate that ICE can be a safe and effective alternative, potentially reducing the need for additional personnel and anesthesia. By comparing ICE to TEE in a larger patient sample, the study seeks to establish a new workflow for the Watchman device implantation.
Who should consider this trial
Good fit: Ideal candidates are patients who meet the established criteria for the Watchman device and are not currently enrolled in another clinical trial.
Not a fit: Patients who cannot undergo TEE or require a concomitant ablation procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify the implantation process and reduce associated risks for patients.
How similar studies have performed: Smaller studies have suggested that ICE can be effective, but this study aims to provide systematic comparison with TEE in a larger cohort.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Oussama Wazni, MD — The Cleveland Clinic
- Study coordinator: Oussama Wazni, MD
- Email: waznio@ccf.org
- Phone: 216-444-2131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.