Atrial Fibrillation, Cardiovascular Diseases, Thromboembolism
Conditions
Keywords
Left atrial appendage closure, Amulet, Watchman, Watchman flx, Acp, Cardiac computed tomography angiography, Transesophageal echocardiography, Peridevice leak, Thromboembolic events, Atrial fibrillation
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).
Interventions
OTHERUse of echocardiography guidance for LAAC
Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 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. |
| Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism | 1 to 5 Years | Protection from cardiovascular death, ischemic stroke and systemic embolism |
| Secondary Efficacy Endpoint - Incidence of technical success | 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 - Total procedure time (min) | During the LAAC Procedure (≃ 60 minutes ) | Total procedure time (min) |
| Feasibility Endpoint - dose of contrast medium (ml) | During the LAAC Procedure (≃ 60 minutes ) | dose of contrast medium (ml) |
| Feasibility Endpoint - dose of x-ray (cGy.cm2) | During the LAAC Procedure (≃ 60 minutes ) | dose of x-ray (cGy.cm2) |
| Feasibility Endpoint - number of device implantation attempt during the procedure (number) | During the LAAC Procedure (≃ 60 minutes ) | number of device implantation attempt during the procedure (number) |
| Feasibility Endpoint - number of device change during the procedure (number) | During the LAAC Procedure (≃ 60 minutes ) | number of device change during the procedure (number) |
| Net Clinical Benefit Endpoint | 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 | 45 days to 13 months | LAA patency and its subtypes as evaluated by TEE and/or CCTA |
| Device related thrombus | 45 days to 13months | Device related thrombus detected by TEE and /or CCTA on the atrial surface of device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of atrial surface of device covered | 45 days - 3 months - 13months | % (device sealing surrogate) |
| Maximal Hypoattentuated Thickening on atrial surface of device | 45 days - 3 months - 13months | mm (device sealing surrogate) |
| Percentage of device length coverage | 45 days - 3 months - 13months | % (device sealing surrogate) |
Countries
Switzerland
Contacts
Primary ContactLorenz Räber, Prof.
Outcome results
None listed