Heart procedure showdown: which imaging method is safer?
NCT ID NCT06348394
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests if using a camera inside the heart (intracardiac echocardiography) is as safe and effective as the standard throat camera (transesophageal echocardiography) for guiding a procedure to close a heart pouch. The goal is to prevent strokes in people with an irregular heartbeat. About 444 participants will be randomly assigned to one of the two methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 444 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor Scott and White Heart Hospital
RECRUITINGPlano, Texas, 75093, United States
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Other studies related to the condition(s) this trial covers.
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