NCT06348394 Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
| NCT ID | NCT06348394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor Research Institute |
| Condition | Left Atrial Appendage Closure |
| Study Type | INTERVENTIONAL |
| Enrollment | 444 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2030-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 444 participants in total. It began in 2025-02-25 with a primary completion date of 2030-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria 1\) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06348394 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Left Atrial Appendage Closure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06348394 currently recruiting?
Yes, NCT06348394 is actively recruiting participants. Contact the research team at Bonnie.Ostergren@BSWHealth.org for enrollment information.
Where is the NCT06348394 trial being conducted?
This trial is being conducted at Plano, United States.
Who is sponsoring the NCT06348394 clinical trial?
NCT06348394 is sponsored by Baylor Research Institute. The trial plans to enroll 444 participants.