Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT06061757
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Imaging guidance with TEE and ICE for Left atrial appendage closure — DEVICE
    The 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.

Study Details

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.

Key Dates

Start date
May 10, 2023
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Success of Implantation of Left Atrial Appendage Closure (LAAC) device [ Time Frame: 1 Day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kansas City Heart Rhythm Institute - Roe ClinicOverland ParkKansas66211
Donita Atkins
[email protected]
816-651-1969
Dhanunjaya Lakkireddy, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Overland Park, KS

By condition
Atrial fibrillationStroke
By specialty
CardiologyHeart diseaseNeurologyBrain disorders
By research site
Kansas City Heart Rhythm Institute - Roe Clinic· Overland Park, KS

Related Studies