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

February 21, 2023 updated by: University Hospital Inselspital, Berne
The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Bern University Hospital Inselspital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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
1 to 5 Years
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)
7 days to 13 months
Feasibility Endpoint - Total procedure time (min)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
Total procedure time (min)
During the LAAC Procedure (≃ 60 minutes )
Feasibility Endpoint - dose of contrast medium (ml)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
dose of contrast medium (ml)
During the LAAC Procedure (≃ 60 minutes )
Feasibility Endpoint - dose of x-ray (cGy.cm2)
Time Frame: During the LAAC Procedure (≃ 60 minutes )
dose of x-ray (cGy.cm2)
During the LAAC Procedure (≃ 60 minutes )
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)
During the LAAC Procedure (≃ 60 minutes )
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)
During the LAAC Procedure (≃ 60 minutes )
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.
1 to 5 years
LAA patency
Time Frame: 45 days to 13 months
LAA patency and its subtypes as evaluated by TEE and/or CCTA
45 days to 13 months
Device related thrombus
Time Frame: 45 days to 13months
Device related thrombus detected by TEE and /or CCTA on the atrial surface of device
45 days to 13months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of atrial surface of device covered
Time Frame: 45 days - 3 months - 13months
% (device sealing surrogate)
45 days - 3 months - 13months
Maximal Hypoattentuated Thickening on atrial surface of device
Time Frame: 45 days - 3 months - 13months
mm (device sealing surrogate)
45 days - 3 months - 13months
Percentage of device length coverage
Time Frame: 45 days - 3 months - 13months
% (device sealing surrogate)
45 days - 3 months - 13months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Lorenz Räber, Prof., Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2015

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01742

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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