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

Recruiting

• Conditions: Atrial Fibrillation; Cardiovascular Diseases; Thromboembolism

• Registration Number: NCT04628078
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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 Timeline

• Study Start: 2015-08-12
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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)
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.
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 - 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 Outcome Measures

Name	Time	Method
Maximal Hypoattentuated Thickening on atrial surface of device	45 days - 3 months - 13months	mm (device sealing surrogate)
Percentage of atrial surface of device covered	45 days - 3 months - 13months	% (device sealing surrogate)
Percentage of device length coverage	45 days - 3 months - 13months	% (device sealing surrogate)

Trial Locations

Locations (1)

Bern University Hospital Inselspital; 🇨🇭 Bern, Switzerland