Clinical trial NCT04628078: LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
Official title: LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Cardiovascular Diseases
Thromboembolism
Keywords: Left atrial appendage closure
Amulet
Watchman
Watchman flx
Acp
Cardiac computed tomography angiography
Transesophageal echocardiography
Peridevice leak
Thromboembolic events
Atrial fibrillation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are scheduled to undergo to an elective Left Atrial Appendage Closure

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

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 7 days
measure: Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
timeFrame: 1 to 5 Years
measure: Secondary Efficacy Endpoint - Incidence of technical success
timeFrame: 7 days to 13 months
measure: Feasibility Endpoint - Total procedure time (min)
timeFrame: During the LAAC Procedure (≃ 60 minutes )
measure: Feasibility Endpoint - dose of contrast medium (ml)
timeFrame: During the LAAC Procedure (≃ 60 minutes )
measure: Feasibility Endpoint - dose of x-ray (cGy.cm2)
timeFrame: During the LAAC Procedure (≃ 60 minutes )
measure: Feasibility Endpoint - number of device implantation attempt during the procedure (number)
timeFrame: During the LAAC Procedure (≃ 60 minutes )
measure: Feasibility Endpoint - number of device change during the procedure (number)
timeFrame: During the LAAC Procedure (≃ 60 minutes )
measure: Net Clinical Benefit Endpoint
timeFrame: 1 to 5 years
measure: LAA patency
timeFrame: 45 days to 13 months
measure: Device related thrombus
timeFrame: 45 days to 13months
Secondary outcomes:
measure: Percentage of atrial surface of device covered
timeFrame: 45 days - 3 months - 13months
measure: Maximal Hypoattentuated Thickening on atrial surface of device
timeFrame: 45 days - 3 months - 13months
measure: Percentage of device length coverage
timeFrame: 45 days - 3 months - 13months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital Inselspital
Study officials:
affiliation: Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie
name: Lorenz Räber, Prof.
role: PRINCIPAL_INVESTIGATOR
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