LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Use of echocardiography guidance for LAAC
Other interventionSince August 2015, the echocardiography is routinely used by majority of operators to guide LAAC
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
Composite of Death, cerebrovascular events, cardiac tamponade, need for urgent surgery, need for cardiopulmonary resuscitation, device embolization, non vascular access-related major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) or acute kidney injury.
Time frame
7 days2
Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
Protection from cardiovascular death, ischemic stroke and systemic embolism
Time frame
1 to 5 Years3
Secondary Efficacy Endpoint - Incidence of technical success
Technical success defined as adequate LAA ostium closure (without residual PDL\>5mm or patent lobes) in absence of device complications (according to the Munich Consensus Document)
Time frame
7 days to 13 months4
Feasibility Endpoint - Total procedure time (min)
Total procedure time (min)
Time frame
During the LAAC Procedure (≃ 60 minutes )Secondary outcomes
1
Percentage of atrial surface of device covered
% (device sealing surrogate)
Time frame
45 days - 3 months - 13months2
Maximal Hypoattentuated Thickening on atrial surface of device
mm (device sealing surrogate)
Time frame
45 days - 3 months - 13months3
Percentage of device length coverage
% (device sealing surrogate)
Time frame
45 days - 3 months - 13monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov