What this study is
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.
What's being tested
- Intracardiac Echocardiography
Intervention · DEVICE
Transesophageal echocardiography will be performed under general anesthesia.
- Traditional transesophageal echocardiography
Intervention · DEVICE
Traditional transesophageal echocardiography guided Left atrial appendage closure
Study details
- Sponsor
- Baylor Research Institute
- Conditions
- Left Atrial Appendage Closure
- Enrolling
- 444 people
- Starts
- 2025-02-25
- Est. completion
- 2030-12-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
- Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥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.
- Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation.
- Ages 18 and above
You can't join if
- Presence of an intracardiac thrombus on the preprocedural TEE or CT.
- History of previously implanted device for atrial septal defect or patent foramen ovale.
- Severe LV dysfunction (LVEF < 40%) or greater than moderate valvular heart disease.
- Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
- Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
- Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
- 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.
- 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
- Children below 18 years, prisoners and patients who are unable to provide consent are excluded.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBaylor Scott and White Heart Hospital
Plano, Texas, United States
- Bonnie Ostergren · Contact4698144181Bonnie.Ostergren@BSWHealth.org
- Sarah Hale · Contact4698144845sarah.hale@bswhealth.org
- Karim Al-Azizi, MD · Principal investigator
Recruiting
Study team
Sponsor
Baylor Research Institute
Study ID 023-318
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.