RECRUITING

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

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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 single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.

Official Title

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Quick Facts

Study Start:2025-02-25

Study Completion:2026-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06348394

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 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF. 2. Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3. 3. Patient suitable for OAC with warfarin or DOAC and have appropriate rationale to seek a nonpharmacologic alternative to long-term OAC, meeting commercial LAAO criteria indications. 4. Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE). 5. Patient should be able to comply with the protocol. 6. Provide written informed consent before study participation. 7. Ages 18 and above 1. Presence of an intracardiac thrombus on the preprocedural TEE or CT. 2. History of previously implanted device for atrial septal defect or patent foramen ovale. 3. Severe LV dysfunction (LVEF \< 40%) or greater than moderate valvular heart disease. 4. Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study. 5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests. 6. Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO. 7. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study. 8. For women of childbearing potential: Pregnant or breastfeeding women or planning pregnancy during the course of the investigation are excluded due to the risks involved in the procedure 9. Children below 18 years, prisoners and patients who are unable to provide consent are excluded.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
2. Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3.
3. Patient suitable for OAC with warfarin or DOAC and have appropriate rationale to seek a nonpharmacologic alternative to long-term OAC, meeting commercial LAAO criteria indications.
4. Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
5. Patient should be able to comply with the protocol.
6. Provide written informed consent before study participation.
7. Ages 18 and above
1. Presence of an intracardiac thrombus on the preprocedural TEE or CT.
2. History of previously implanted device for atrial septal defect or patent foramen ovale.
3. Severe LV dysfunction (LVEF \< 40%) or greater than moderate valvular heart disease.
4. Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
6. Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
7. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
8. For women of childbearing potential: Pregnant or breastfeeding women or planning pregnancy during the course of the investigation are excluded due to the risks involved in the procedure
9. Children below 18 years, prisoners and patients who are unable to provide consent are excluded.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Bonnie Ostergren

CONTACT

4698144181

Bonnie.Ostergren@BSWHealth.org

Study Locations (Sites)

Baylor Scott and White Heart Hospital

Plano, Texas, 75093

United States

Collaborators and Investigators

Sponsor: Baylor Research 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 Date2025-02-25

Study Completion Date2026-12-30

Study Record Updates

Study Start Date2025-02-25

Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

Left Atrial Appendage Closure