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NCT Number: NCT04628078

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Cerebral Palsy, Ataxic, Autosomal Recessive Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bern University Hospital Inselspital

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Lorenz Räber, Prof.

CONTACT

[email protected]

+41 31 632 09 29

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of echocardiography guidance for LAAC

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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)

  4. Feasibility Endpoint - Total procedure time (min)

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

    Total procedure time (min)

  5. Feasibility Endpoint - dose of contrast medium (ml)

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

    dose of contrast medium (ml)

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

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

    dose of x-ray (cGy.cm2)

  7. 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)

  8. 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)

  9. 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.

  10. LAA patency

    Time frame: 45 days to 13 months

    LAA patency and its subtypes as evaluated by TEE and/or CCTA

  11. 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

  1. Percentage of atrial surface of device covered

    Time frame: 45 days - 3 months - 13months

    % (device sealing surrogate)

  2. Maximal Hypoattentuated Thickening on atrial surface of device

    Time frame: 45 days - 3 months - 13months

    mm (device sealing surrogate)

  3. Percentage of device length coverage

    Time frame: 45 days - 3 months - 13months

    % (device sealing surrogate)

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenz Räber, Prof.

CONTACT

[email protected]

31 632 09 29 ext. +41

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2027
First posted
Nov 13, 2020
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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