Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKansas City Heart Rhythm Research Foundation
About this trial
This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.
Eligibility criteria
Qualifiers
Male/Females
Age:18-80 years
History of Atrial Fibrillation/Atrial flutter
Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device
Disqualifiers
Inability or unwillingness of an individual to give written informed consent
Patient not following with our practice after the procedure
Complex anatomy for endocardial LAAC
Thrombus in LAA
Trial design
Treatments tested in this trial
- Imaging guidance with TEE and ICE for Left atrial appendage closure
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov