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

Atrial Fibrillation Clinical Trial

— ESCALLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465459
• Other study ID #: 2024-A00420-47
• Status: Recruiting
• Start date: June 14, 2024
• Est. completion date: June 14, 2027

Study information

• Verified date: June 2024
• Source: French Cardiology Society
• Contact: Xavier IRIART
• Phone: (+33) 5.57.65.64.65
• Email: xavier.iriart[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 14, 2027
• Est. primary completion date: June 14, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• LAMBRE device implantation
LAMBRE device implantation

Locations

Country	Name	City	State
France	Hôpital Cardiologique de Haut Lévêque	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device
Secondary	To evaluate the effectiveness of the device	The success rate of the procedure at the end of implantation	end of procedure
Secondary	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	at 3 months after implantation
Secondary	To evaluate the effectiveness of the device	the positioning of the prosthesis	at 3 months after implantation
Secondary	To evaluate the effectiveness of the device	the rate of periprosthetic shunts on the atrial side of the prosthesis	at 3 months after implantation
Secondary	To evaluate the effectiveness of the device	the rate of periprosthetic thrombus on the atrial side of the prosthesis	at 3 months after implantation
Secondary	To evaluate the effectiveness of the device	The rate of ischemic stroke	at 1 year after implantation
Secondary	To evaluate the effectiveness of the device	The rate of TIA	at 1 year after implantation
Secondary	To evaluate the effectiveness of the device	The rate of systemic embolism	at 1 year after implantation
Secondary	To evaluate the effectiveness of the device	The rate of death of cardiovascular or unexplained origin	at 1 year after implantation
Secondary	To evaluate the effectiveness of the device	The rate of death	at 1 year after implantation
Secondary	To evaluate the effectiveness of the device	The comparison of the frequency of ischemic cerebral or systemic accidents to the theoretical predicted value	at 1 year after implantation
Secondary	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	at the pre-discharge examination (up to 3 days)
Secondary	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	at 3 months
Secondary	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	at 1 year
Secondary	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	during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device
Secondary	Description of the population and centers	demographic and clinical characteristics of patients	at baseline
Secondary	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.	at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation