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

Insel Gruppe AG, University Hospital Bern1,000 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Atrial Fibrillation Cardiovascular Diseases Thromboembolism

Interventions

Use of echocardiography guidance for LAACOTHER

Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bern University Hospital Inselspital

Bern, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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 days

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 Years

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 months

Feasibility Endpoint - Total procedure time (min)

Total procedure time (min)

Time frame: During the LAAC Procedure (≃ 60 minutes )

Feasibility Endpoint - dose of contrast medium (ml)

dose of contrast medium (ml)

Time frame: During the LAAC Procedure (≃ 60 minutes )

Feasibility Endpoint - dose of x-ray (cGy.cm2)

dose of x-ray (cGy.cm2)

Time frame: During the LAAC Procedure (≃ 60 minutes )

Feasibility Endpoint - number of device implantation attempt during the procedure (number)

number of device implantation attempt during the procedure (number)

Time frame: During the LAAC Procedure (≃ 60 minutes )

Central Contacts

Lorenz Räber, Prof.

CONTACT

31 632 09 29 lorenz.raeber@insel.ch

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes