RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-10
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06061757

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male/Females
  2. * Age:18-80 years
  3. * History of Atrial Fibrillation/Atrial flutter
  4. * Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device
  1. * Inability or unwillingness of an individual to give written informed consent
  2. * Patient not following with our practice after the procedure
  3. * Complex anatomy for endocardial LAAC
  4. * Thrombus in LAA
  5. * Patients with pericardial effusion in pre-op TEE/CCTA
  6. * Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)

Contacts and Locations

Study Contact

Donita Atkins
CONTACT
816-651-1969
datkins@kchrf.com

Principal Investigator

Dhanunjaya Lakkireddy, MD
PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Kansas City Heart Rhythm Research Foundation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-05-10
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Stroke