Recruiting

4D-ICE

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT06061757

Conditions

Atrial Fibrillation

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Imaging guidance with TEE and ICE for Left atrial appendage closure

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Stroke

Study ID

NCT06061757

Start date

May 10, 2023

Status verified date

Oct, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with pericardial effusion in pre-op TEE/CCTA
  • Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)

Study Design

Enrollment

52 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

Imaging guidance with TEE and ICE for Left atrial appendage closure

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Kansas City Heart Rhythm Institute - Roe Clinic

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Dhanunjaya Lakkireddy, MD

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Aug 28, 2025

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2025-08-28.