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NCT Number: NCT06465459

Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure

Atrial fibrillation (AF) is responsible for 15-20% of ischaemic strokes. These events are often caused by thrombus formation in the left atrium. Thromboembolic risk in AF is primarily prevented by oral anticoagulation. However, this drug-based approach has a number of limitations, the most important of which are compliance problems and, above all, the risk of haemorrhagic complications, some of which are potentially serious. Left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated.

The CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE, LIFETCH prosthesis, a device for transcatheter closure of the left atrial appendage, is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score ≥ 4 and a formal and permanent contraindication to anticoagulants (validated by a multidisciplinary committee).

LAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee. Among the criteria analysed regarding the efficacy and safety of the device implantation, the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cardiologique de Haut Lévêque

Pessac, 33600, France

Location status: Recruiting

Location contact

Xavier IRIART

CONTACT

[email protected]

(+33)1 44 90 70 29

About this study

This is a non-interventional, prospective and retrospective national multicentre study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient requiring a left atrial exclusion procedure according to the recommendations by the CNEDiMTS and HAS using the LAMBRE device
  • Age ≥18 years
  • Patient has been informed of the nature of the study and agrees to participate

Exclusion criteria

  • Minor patient
  • Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)

Treatment and study plan

LAMBRE device implantation

Procedure

LAMBRE device implantation

Primary outcomes

  1. To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device.

    Time frame: during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device

    the occurrence of one of the following events: ischaemic stroke, systemic embolism, rate of device migration and death of cardiovascular or unexplained origin occurring in patients implanted with a left atrial closure device.

Secondary outcomes

  1. To evaluate the effectiveness of the device

    Time frame: end of procedure

    The success rate of the procedure at the end of implantation

  2. To evaluate the effectiveness of the device

    Time frame: at 3 months after implantation

    the results of the scanner and/or transesophageal ultrasound concerning the rate of occlusion of the left auricle

  3. To evaluate the effectiveness of the device

    Time frame: at 3 months after implantation

    the positioning of the prosthesis

  4. To evaluate the effectiveness of the device

    Time frame: at 3 months after implantation

    the rate of periprosthetic shunts on the atrial side of the prosthesis

  5. To evaluate the effectiveness of the device

    Time frame: at 3 months after implantation

    the rate of periprosthetic thrombus on the atrial side of the prosthesis

  6. To evaluate the effectiveness of the device

    Time frame: at 1 year after implantation

    The rate of ischemic stroke

  7. To evaluate the effectiveness of the device

    Time frame: at 1 year after implantation

    The rate of TIA

  8. To evaluate the effectiveness of the device

    Time frame: at 1 year after implantation

    The rate of systemic embolism

  9. To evaluate the effectiveness of the device

    Time frame: at 1 year after implantation

    The rate of death of cardiovascular or unexplained origin

  10. To evaluate the effectiveness of the device

    Time frame: at 1 year after implantation

    The rate of death

  11. To evaluate the effectiveness of the device

    Time frame: at 1 year after implantation

    The comparison of the frequency of ischemic cerebral or systemic accidents to the theoretical predicted value

  12. To evaluate the tolerance of the procedure and the device

    Time frame: at the pre-discharge examination (up to 3 days)

    Complications linked or potentially linked to the implantation procedure or the device, percentage of device migration or pericardial effusion by trans-thoracic or trans-esophageal ultrasound

  13. To evaluate the tolerance of the procedure and the device

    Time frame: at 3 months

    percentage of thrombosis on prosthesis or migration of the prosthesis by scanner and/or in the absence of trans-esophageal ultrasound

  14. To evaluate the tolerance of the procedure and the device

    Time frame: at 1 year

    Percentage of major and/or life-threatening bleeding complications and total percentage of complications related or potentially related to the procedure or device

  15. Description of bleeding complications not related to the device or procedure

    Time frame: during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device

    Percentage of patients who experienced at least one bleeding complication unrelated to the device or procedure during the entire study

  16. Description of the population and centers

    Time frame: at baseline

    demographic and clinical characteristics of patients

  17. Description of antithrombotic treatments prescribed following implantation of the device

    Time frame: at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation

    Percentage of patients on injectable or oral anticoagulants and on antiplatelet agents at the different follow-up times, Percentage of patients on injectable or oral anticoagulants at different follow-up times, Percentage of patients on antiplatelet agents in mono or dual therapy at the different follow-up times, Average duration of anticoagulant and antiplatelet treatments.

Study contacts

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

Dr Xavier IRIART

CONTACT

[email protected]

(+33) 1 44 90 70 29

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

Registry information

Official study title

ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure

Acronym: ESCALLE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Mar 2, 2026

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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