Comparing outcomes of left atrial appendage closure in patients with atrial fibrillation
LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
This study looks at how well different methods of closing a part of the heart help people with atrial fibrillation and what factors might affect the results over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04628078 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze clinical and imaging outcomes from patients undergoing left atrial appendage closure (LAAC) for atrial fibrillation. It will assess the impact of various patient characteristics and procedural techniques on the safety and efficacy of LAAC. Data will be gathered through procedural records and follow-up evaluations at 1, 3, and 5 years, including imaging exams such as transesophageal echocardiography and coronary computed tomography angiography. The study focuses on a large cohort of patients to provide insights into the effectiveness of different LAAC approaches.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with non-valvular atrial fibrillation and a CHA2DS2-VASc Score of 2 or higher who are scheduled for elective LAAC.
Not a fit: Patients who are unwilling to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of LAAC outcomes, leading to improved treatment strategies for patients with atrial fibrillation.
How similar studies have performed: Other studies have shown promising results with LAAC procedures, indicating that this approach is both established and beneficial for similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\> 18 * Written informed consent to participate in the study * Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are planned for an elective LAA-closure * Anatomic characteristics allow placement of a CE marked device, dedicated for LAAC Exclusion Criteria: * None. Considering the nature of the project, which is to prospectively collect information on all patients treated with LAAC in our center, we will only exclude patients unwilling to sign the informed consent.
Where this trial is running
Bern
- Bern University Hospital Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Lorenz Räber, Prof. — Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie
- Study coordinator: Lorenz Räber, Prof.
- Email: lorenz.raeber@insel.ch
- Phone: 31 632 09 29
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.