LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Thromboembolism; Atrial Fibrillation; Cardiovascular Diseases

Treatments: Other: Use of echocardiography guidance for LAAC

Study type: Observational

Funder types: Other

Identifiers

NCT04628078

2016-01742

Details and patient eligibility

About

The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.

Full description

Percutaneous left atrial appendage closure (LAAC) has established itself in clinical practice as a safe and efficient therapeutic option for atrial fibrillation patients with a relative/absolute contraindication to oral anticoagulation. The purpose of this observational study is to prospectively collect procedural and follow-up data of all patients submitted to a clinically indicate LAAC in order to assess the impact of patient characteristics, procedural technique (imaging used to guide/plan procedure, device implanted, post-procedural drug regimens, etc.) on procedural safety and efficacy. The endpoints will be assessed by means of clinical follow-up at 1-3-5 years after LAAC and imaging exams (TEE at1-3 months, CCTA at 1-13months).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.