Intracardiac Echocardiography Guided Watchman Device Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Intracardiac Echocardiography (ICE)
DeviceICE will be used to guide trans-septal puncture and to guide device implant.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful Watchman implantation using intracardiac echocardiography (ICE) guidance
Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)
Time frame
During the procedureSponsors and contacts
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Source ClinicalTrials.gov