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

Description

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 Overview

Study Details

Study overview

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.

Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)

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

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Overland Park

Kansas City Heart Rhythm Institute - Roe Clinic, Overland Park, Kansas, United States, 66211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kansas City Heart Rhythm Research Foundation,

Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

Study Record Dates

2025-12-31