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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Imaging guidance with TEE and ICE for Left atrial appendage closure
DeviceThe occluder size for both LAAC devices will be selected based on the maximal diameter of the LAA orifice following the manufacturer guidelines and using the maximal length of the LAA measured on Echocardiogram. Intraprocedural measurements of the LAA width and depth were acquired on both ICE and TEE per protocol. Both ICE and TEE will be used to assess for any procedural complications prior to insertion of the device delivery sheath.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - TEE Primary imaging guidanceExperimental treatment 1 intervention
Group B: Arm 2 - ICE Primary Imaging GuidanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Success of Implantation of Left Atrial Appendage Closure (LAAC) device
Success of Implantation of Amulet or Watchman FLX device
Time frame
1 DaySecondary outcomes
1
Intraprocedural measurements
Transeptal access view, LAA thrombus, Stability of the device, Peri-device leaks, Device Repositioning, Clarity of mitral valve or pulmonary vein impingement will be noted as Yes/No from Echocardiogram
Time frame
1 Day2
Intraprocedural measurements
LAA size in different sites will be noted from Echocardiograms
Time frame
1 Day3
Intraprocedural measurements - LAA device size
LAA device size will be measured based on the LAA size
Time frame
1 Day4
Location of the leaks
Location of the leaks will be identified
Time frame
1 DayOther outcomes
1
Post Procedural Outcomes
Presence of any Peri-device leaks (PDL), Device Related Thrombus (DRTs), Micro migration and device tilt will be noted.
Time frame
45 Days, 6 Months and 12 Months2
Post Procedural Outcomes - Size of the leaks
Leaks if any, leaks size will be measured
Time frame
45 Days, 6 Months and 12 MonthsSponsors and contacts
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Source ClinicalTrials.gov