Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Kansas
Kansas City Heart Rhythm Institute - Roe Clinic
RECRUITING
Overland Park
Contact Information
Primary
Donita Atkins
datkins@kchrf.com
816-651-1969
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 52
Treatments
Experimental: Arm 1 - TEE Primary imaging guidance
TEE is the primary imaging guidance with 4D ICE is the secondary
Experimental: Arm 2 - ICE Primary Imaging Guidance
4D ICE is the primary imaging guidance and TEE is the secondary
Related Therapeutic Areas
Sponsors
Leads: Kansas City Heart Rhythm Research Foundation