Comparing 3D Echocardiography with CT for Planning Atrial Appendage Closure
Evaluation of 3D Simulation and Planning of Left Atrial Appendage Occlusion Based on 3D Echocardiography
This study is testing a new 3D ultrasound method for planning a heart procedure to see if it works better than the traditional CT scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Genk, Limburg and 1 other locations) |
| Trial ID | NCT05926037 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a semi-automatic 3D echocardiography-based planning method for left atrial appendage occlusion (LAAO) compared to the traditional CT-based approach. It involves measuring the dimensions of the left atrial appendage and predicting device sizing and deformation using both imaging techniques. The study will analyze the success rate of the 3D echocardiography method in providing complete reports and compare it to the established gold standard. Various endpoints will be assessed to determine the feasibility and accuracy of this new approach.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for LAAO with an Amplatzer Amulet device at participating Belgian centers.
Not a fit: Patients with contraindications for contrast or radiation exposure, or those unable to undergo CT analysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the precision of LAAO procedures, leading to better patient outcomes.
How similar studies have performed: While similar imaging approaches have been explored, this specific comparison of 3D echocardiography with CT for LAAO planning is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients planned for LAAO with an Amplatzer Amulet Left Atrial Appendage Occluder (Abbott Medical) * clinical indication (in line with currently accepted indications and national reimbursement criteria) * inclusion in 2 experienced Belgian LAAO centers (Brussels and Genk) Exclusion Criteria: * contra-indication for contrast (including contrast allergy and renal failure), * contra-indication for radiation exposure (e.g. pregnancy) * Inability by FEops to analyze CT images and provide a report
Where this trial is running
Genk, Limburg and 1 other locations
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (Recruiting)
- Universitair Ziekenhuis Brussel — Jette, Belgium (Recruiting)
Study contacts
- Study coordinator: Stijn Lochy, MD
- Email: stijn.lochy@uzbrussel.be
- Phone: 03224776008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.