LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
Time Frame: 1 to 5 Years
Protection from cardiovascular death, ischemic stroke and systemic embolism
Feasibility Endpoint - Total procedure time (min)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
Total procedure time (min)
Feasibility Endpoint - dose of contrast medium (ml)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
dose of contrast medium (ml)
Feasibility Endpoint - dose of x-ray (cGy.cm2)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
dose of x-ray (cGy.cm2)
Feasibility Endpoint - number of device implantation attempt during the procedure (number)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
number of device implantation attempt during the procedure (number)
Primary Safety Endpoint
Time Frame: 7 days
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.
Secondary Efficacy Endpoint - Incidence of technical success
Time Frame: 7 days to 13 months
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)
Feasibility Endpoint - number of device change during the procedure (number)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
number of device change during the procedure (number)
Net Clinical Benefit Endpoint
Time Frame: 1 to 5 years
Composite of death, stroke, systemic embolism, pulmonary embolism, myocardial infarction, and major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) not procedure-related.
LAA patency
Time Frame: 45 days to 13 months
LAA patency and its subtypes as evaluated by TEE and/or CCTA
Device related thrombus
Time Frame: 45 days to 13months
Device related thrombus detected by TEE and /or CCTA on the atrial surface of device
Secondary Outcomes
- Maximal Hypoattentuated Thickening on atrial surface of device(45 days - 3 months - 13months)
- Percentage of atrial surface of device covered(45 days - 3 months - 13months)
- Percentage of device length coverage(45 days - 3 months - 13months)