Intracardiac versus transesophageal guidance for left atrial appendage closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, randomized comparison of ICE-guided versus TEE-guided percutaneous left atrial appendage occlusion (LAAO). Participants have non-valvular atrial fibrillation and are at elevated stroke risk and are suitable candidates for commercial LAAO devices. The primary endpoint is procedural success defined by correct device position without device-related complications and no peri-device leak >5 mm; secondary endpoints include periprocedural complications, procedural metrics, hospital cost and patient satisfaction, and clinical status at 45 days. Procedures, imaging protocols, and follow-up are standardized and outcomes are collected in-hospital and at a 45-day visit.

Why it matters

Who can join: the full rules

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.

Where it's running

• Baylor Scott and White Heart Hospital
  Plano, Texas, United States Recruiting

Study contacts

• Study coordinator: Bonnie Ostergren
• Email: Bonnie.Ostergren@BSWHealth.org
• Phone: 4698144181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tailored lower‑intensity blood thinner plan after left atrial appendage closure to prevent stroke

  This project tests whether people with non‑valvular atrial fibrillation who get a left atrial appendage closure can stop blood thinners after taking low‑dose apixaban (2.5 mg twice daily) for 3 months, compared with people who stay on standard‑dose DOACs.

  Recruiting National Medical Research Center for Therapy and Preventive Medicine · Moscow · NCT07575867

• Agilis RF system to cross the atrial septum for left heart access

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  Recruiting at 3 sites Abbott Medical Devices · Jonesboro, Arkansas and 2 other locations · NCT07361445

• Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure in AF Patients

  In patients with atrial fibrillation who need both ablation and left atrial appendage closure, this study tests doing both procedures in a single intervention using FARAPULSE PFA and a WATCHMAN FLX device.

  Recruiting at 10 sites Boston Scientific Corporation · Aalst and 10 other locations · NCT07349121

• No blood-thinners versus aspirin after left atrial appendage closure

  This trial tests whether skipping antithrombotic drugs after left atrial appendage closure (using only 45 days of oral anticoagulant) is as safe and effective as taking aspirin for people with nonvalvular atrial fibrillation who are at high bleeding risk.

  Recruiting at 20 sites Phase 4 OCEAN-SHD Study Group · Nagoya, Aichi-ken and 20 other locations · NCT07125417

• Comparing LAAO and anticoagulation in stroke patients

  This study is testing if adding a procedure to close off a part of the heart can help stroke patients who are already taking blood thinners and still having strokes.

  Recruiting Hospital Clinic of Barcelona · Barcelona, Barcelona · NCT06869811

• Registry documenting left atrial appendage closure procedures in Austria

  This study is collecting information on patients with atrial fibrillation in Austria who have had a left atrial appendage closure procedure because they can't take blood thinners, to see how safe and effective the treatment is.

  Recruiting Medical University of Graz · Graz · NCT03409159

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.