Atrial FibrillationESCALLENCT06465459
Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
An observational study of Atrial Fibrillation, run by French Cardiology Society at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LAMBRE device implantation
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2024to Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be included in cardiology departments participating in the study. Non-valvular atrial fibrillation patients at high cardio-embolic risk, contraindicated to anticoagulants, scheduled for percutaneous left atrial closure with implantation of the Lambre device will be included in the protocol and monitored as part of their care by the centers that performed the procedure.
Who may be able to join
- 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
Who cannot join
- Minor patient
- Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologique de Haut Lévêque
Pessac, 33600
Xavier IRIART, (+33)1 44 90 70 29, escalle@sfcardio.fr
About this study
Official title: ESCALLE : 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.
Read the detailed description
This is a non-interventional, prospective and retrospective national multicentre study.
- Conditions
- Atrial Fibrillation
- Being tested
- LAMBRE device implantation
- Keywords
- non-valvular atrial fibrillation, atrial fibrillation, LAMBRE system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAMBRE device implantationProcedure or surgery
LAMBRE device implantation
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for percutaneous left atrial closure with Lambre device implantation. | Not described Receives: Procedure: LAMBRE device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure 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.
Measured: during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device
Secondary outcomes (17)
To evaluate the effectiveness of the device
The success rate of the procedure at the end of implantation
Measured: end of procedure
To evaluate the effectiveness of the device
the results of the scanner and/or transesophageal ultrasound concerning the rate of occlusion of the left auricle
Measured: at 3 months after implantation
To evaluate the effectiveness of the device
the positioning of the prosthesis
Measured: at 3 months after implantation
To evaluate the effectiveness of the device
the rate of periprosthetic shunts on the atrial side of the prosthesis
Measured: at 3 months after implantation
To evaluate the effectiveness of the device
the rate of periprosthetic thrombus on the atrial side of the prosthesis
Measured: at 3 months after implantation
To evaluate the effectiveness of the device
The rate of ischemic stroke
Measured: at 1 year after implantation
To evaluate the effectiveness of the device
The rate of TIA
Measured: at 1 year after implantation
To evaluate the effectiveness of the device
The rate of systemic embolism
Measured: at 1 year after implantation
To evaluate the effectiveness of the device
The rate of death of cardiovascular or unexplained origin
Measured: at 1 year after implantation
To evaluate the effectiveness of the device
The rate of death
Measured: at 1 year after implantation
To evaluate the effectiveness of the device
The comparison of the frequency of ischemic cerebral or systemic accidents to the theoretical predicted value
Measured: at 1 year after implantation
To evaluate the tolerance of the procedure and the device
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
Measured: at the pre-discharge examination (up to 3 days)
To evaluate the tolerance of the procedure and the device
percentage of thrombosis on prosthesis or migration of the prosthesis by scanner and/or in the absence of trans-esophageal ultrasound
Measured: at 3 months
To evaluate the tolerance of the procedure and the device
Percentage of major and/or life-threatening bleeding complications and total percentage of complications related or potentially related to the procedure or device
Measured: at 1 year
Description of bleeding complications not related to the device or procedure
Percentage of patients who experienced at least one bleeding complication unrelated to the device or procedure during the entire study
Measured: during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device
Description of the population and centers
demographic and clinical characteristics of patients
Measured: at baseline
Description of antithrombotic treatments prescribed following implantation of the device
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.
Measured: at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start10 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 220 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xavier IRIART, Principal investigator, Hôpital Cardiologique de Haut Lévêque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465459
- Sponsor's protocol ID
- 2024-A00420-47
- Acronym
- ESCALLE
- Status last verified
- Feb 2026
- First submitted
- 29 May 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure
- ClinicalTrials.gov ID
- NCT06465459
- Acronym / sponsor ID
- ESCALLE / 2024-A00420-47
- Conditions
- Atrial Fibrillation
- Keywords
- non-valvular atrial fibrillation, atrial fibrillation, LAMBRE system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-interventional, prospective and retrospective national multicentre study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for percutaneous left atrial closure with Lambre device implantation. | – | Procedure: LAMBRE device implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be included in cardiology departments participating in the study. Non-valvular atrial fibrillation patients at high cardio-embolic risk, contraindicated to anticoagulants, scheduled for percutaneous left atrial closure with implantation of the Lambre device will be included in the protocol and monitored as part of their care by the centers that performed the procedure.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Minor patient
- Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAMBRE device implantationLAMBRE device implantation | Procedure or surgery | Patients scheduled for percutaneous left atrial closure with Lambre device implantation. |
Primary outcome
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.
17 secondary outcomes
To evaluate the effectiveness of the device
Time frame: end of procedure
To evaluate the effectiveness of the device
Time frame: at 3 months after implantation
To evaluate the effectiveness of the device
Time frame: at 3 months after implantation
To evaluate the effectiveness of the device
Time frame: at 3 months after implantation
To evaluate the effectiveness of the device
Time frame: at 3 months after implantation
To evaluate the effectiveness of the device
Time frame: at 1 year after implantation
To evaluate the effectiveness of the device
Time frame: at 1 year after implantation
To evaluate the effectiveness of the device
Time frame: at 1 year after implantation
To evaluate the effectiveness of the device
Time frame: at 1 year after implantation
To evaluate the effectiveness of the device
Time frame: at 1 year after implantation
To evaluate the effectiveness of the device
Time frame: at 1 year after implantation
To evaluate the tolerance of the procedure and the device
Time frame: at the pre-discharge examination (up to 3 days)
To evaluate the tolerance of the procedure and the device
Time frame: at 3 months
To evaluate the tolerance of the procedure and the device
Time frame: at 1 year
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
Description of the population and centers
Time frame: at baseline
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xavier IRIART principal investigator
Hôpital Cardiologique de Haut Lévêque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Xavier IRIART ((+33) 1 44 90 70 29, escalle@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.