Evaluating imaging techniques for left atrial appendage closure
The Role of Multimodality Imaging in Left Atrial Appendage Closure
NA · Hungarian Institute of Cardiology · NCT04800913
This study is testing whether using multiple imaging techniques during left atrial appendage closure procedures is safer and better at spotting complications compared to using just one technique.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hungarian Institute of Cardiology (other gov) |
| Drugs / interventions | radiation |
| Locations | 1 site (Budapest) |
| Trial ID | NCT04800913 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized study aims to compare the effectiveness and safety of unimodal versus multimodal imaging techniques in patients undergoing left atrial appendage closure (LAAC) procedures. The study will assess the procedural burden, including radiation dose and procedure time, while also evaluating the accuracy of postoperative imaging in detecting complications. By analyzing the outcomes of these imaging approaches, the study seeks to determine if multimodal imaging provides significant advantages over unimodal imaging in terms of safety and complication detection.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who require LAAC due to contraindications for long-term anticoagulant therapy.
Not a fit: Patients with active infections, significant mitral valve stenosis, or those requiring open heart surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of LAAC procedures, potentially reducing stroke risk for patients with atrial fibrillation.
How similar studies have performed: While there have been studies on LAAC procedures, the specific comparison of unimodal versus multimodal imaging techniques in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients, who have clinical indication to LAAC and are undergoing percutaneous LAAC procedure in Gottsegen National Cardiovascular Center from 10.03.2021 to 31.12.2025 * Age above 18 years * Informed consent * Legal capacity Exclusion Criteria: * Age under 18 years * Pregnancy * Incapacitation * Absence of consent * Esophageal stenosis or diverticulum * Active esophageal bleeding * CT-contrast agent allergy * Severe chronic kidney disease (GFR\<15 ml/min/1,73 m2) * Appendage thrombus (mobile/with significant embolic risk) * Life expectancy shorter than 12 months * Active infection * Significant mitral valve stenosis * Mechanical heart valve * Open heart surgery is indicated
Where this trial is running
Budapest
- Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center) — Budapest, Hungary (RECRUITING)
Study contacts
- Principal investigator: Anita Zadori, MD, PhD — 0036303837011, anita.zadori@gokvi.hu
- Study coordinator: Peter Andreka, MD, PhD
- Email: peter.andreka@gokvi.hu
- Phone: 0036703820470
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.
Conditions: Atrial Fibrillation, atrial fibrillation, ischemic stroke, left atrial appendage closure, bleeding