4D intracardiac echocardiography to guide left atrial appendage occlusion procedures

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 prospective feasibility study tests a prototype 4D intracardiac echocardiography (ICE) catheter used with a commercial ultrasound system during structural heart and electrophysiology procedures. TEE remains the primary imaging modality, while ICE provides adjunct imaging data and workflow information without changing the approved device indications. The study aims to compare image quality and measurement accuracy between 4D ICE and TEE, while evaluating safety and procedure efficiency. Procedures use commercially available Watchman devices, with no investigational implants. Participants must meet specific criteria and avoid certain conditions to participate.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be aged above 18 for adult participants
2. Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures.
3. Be able and willing to give informed consent
4. (For concomitant cases only) Ablation will occur prior to LAAO implantation

Exclusion Criteria:

Potential subjects must not include:

1. Subjects who are currently enrolled in any other investigational clinical studies
2. Subjects with any bleeding diathesis
3. Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
4. Subjects with known intracardiac thrombus
5. Subjects with myocardial infarction within the prior two months
6. Subjects with class IV angina or heart failure
7. Subjects with sepsis or active infection
8. Subjects with immune-deficiency or immune-compromised status
9. Subjects with cerebral ischemic event in the prior six months
10. Subjects with deep vein thrombosis

Where it's running

• Cleveland Clinical Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Walid Saliba, MD — The Cleveland Clinic
• Study coordinator: Walid Saliba, MD
• Email: salibaw@ccf.org
• Phone: 216-444-6810

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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.