Observational Study of Clinical Outcomes After Echocardiography-Guided Left Atrial Appendage Closure in Atrial Fibrillation Patients
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-02-22
1000
Participants Needed
1
Research Sites
208 weeks
Total Duration
AI-Summary
What this Trial Is About
This observational study focuses on patients with atrial fibrillation who undergo left atrial appendage closure LAAC. It aims to compare clinical and imaging outcomes across different patient subgroups to understand the effects of patient characteristics and procedural techniques on safety and effectiveness. The study is sponsored by Insel Gruppe AG, University Hospital Bern, and follows patients over several years to gather important data about LAAC in real-world clinical practice.
The study collects data from patients undergoing clinically indicated LAAC, guided mainly by echocardiography since 2015. Researchers track procedural details including imaging methods, devices used for closure, and post-procedure drug treatments. Follow-up includes clinical visits and imaging exams such as transesophageal echocardiography TEE at 1 to 3 months and cardiac computed tomography angiography CCTA between 1 and 13 months after the procedure.
Participants will be monitored through clinical follow-ups at 1, 3, and 5 years to assess safety events like cardiovascular death and stroke, as well as technical success and device-related outcomes. The study also measures procedure time, contrast medium dose, and x-ray exposure during LAAC. Researchers evaluate device coverage and potential thrombus formation using imaging. Total participation may extend up to 5 years to capture long-term results and safety information.
CONDITIONS
Brief Title
LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
Research Team
L
Lorenz Räber, Prof.
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Written informed consent to participate in the study
Patients with paroxysmal, persistent, or permanent non-valvular atrial fibrillation and a CHA2DS2-VASc score of 2 or higher
Anatomic characteristics suitable for placement of a CE marked device dedicated for left atrial appendage closure
You will not qualify if you...
Patients unwilling to sign informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Approximately 60 minutes
Participants undergo clinically indicated left atrial appendage closure guided by echocardiography.
1 procedure visit
Post-operative Follow-up
Duration - 1 to 5 years
Participants have clinical and imaging follow-up to assess procedural safety, device efficacy, and patient outcomes.
Clinical follow-up visits at 1, 3, and 5 years; imaging visits including TEE at 1 and 3 months and CCTA at 1 and 13 months
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.