Actively Recruiting

Age: 18Years +
All Genders
ID04628078

LAAC-registry: Clinical Outcome After Echocardiography-guided Left Atrial Appendage Closure

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-02-22

1000

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18
  • 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
Not Eligible

You will not qualify if you...

  • Patients unwilling to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

Bern University Hospital Inselspital

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

L

Lorenz Räber, Prof.

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

Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010.

Valery L Feigin, Mohammad H Forouzanfar, Rita Krishnamurthi...

https://pubmed.ncbi.nlm.nih.gov/24449944

Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis.

David R Holmes, Shephal K Doshi, Saibal Kar...

https://pubmed.ncbi.nlm.nih.gov/26088300

Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial.

David R Holmes, Saibal Kar, Matthew J Price...

https://pubmed.ncbi.nlm.nih.gov/24998121

Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices.

Konstantinos C Koskinas, Samera Shakir, Máté Fankhauser...

https://pubmed.ncbi.nlm.nih.gov/27388826

Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.

David R Holmes, Vivek Y Reddy, Zoltan G Turi...

https://pubmed.ncbi.nlm.nih.gov/19683639

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

A Pieter Kappetein, Stuart J Head, Philippe Généreux...

https://pubmed.ncbi.nlm.nih.gov/23026477