Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study

NCT03666780 | Completed DMC

• 1 other identifier: LA-PMCF-01
• Study Type: observational
• Target: 500
• Locations: 9 countries
• Sites: 26

Brief Summary

Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate the immediate and long-term procedural success of Lifetech LAmbre™ occluders in patients.

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage Occluder; LAmbre; Lifetech LAA; Lifetech LAmbre; LT LAA; Left Atrial Appendage

Outcome Measures

Primary Outcomes (2)

• Absence of peri-procedural stroke/TIA, device embolization, cardiac or vascular perforation, any other device or procedure-related serious adverse event or death (procedure or device-related or of unknown cause);

  Peri-procedure defined as within 7 days of the procedure.

  Within 7 days post-procedure.

• Implant success.

  Implant success is defined as the correct positioning and release of the occluder device into the proper anatomical location. Correct positioning is assessed as the absence of major residual jet flow (\>5mm) into the LAA closure with the device evaluated by the transesophageal echocardiogram (TEE).

  At procedure.

Secondary Outcomes (4)

• Incidence of stroke or systemic embolism or death through 3 years post-implantation.

  From attempted procedure to 3 years post-implantation

• Successful sealing around the device at the LAA orifice with residual jet ≤5 mm flow measured by TEE at 1-3 months, 6 months post-implantation.

  1-3 months, 6 months post-implantation

• Device or procedure-related Serious Adverse Events (SAEs) from attempted procedure through 3 years post-implantation

  From attempted procedure to 3 years post-implantation

• All SAEs (death included) from attempted procedure through 3 years post-implantation.

  From attempted procedure to 3 years post-implantation

Study Arms (1)

Subject

All patients who signed informed consent and are implanted with a Lifetech LAmbre occluder device will undergo follow-up (FU) evaluations as per local hospital standards and corresponding IFU which is expected to be at the following time points post-implant: * At discharge (+/- 1 day) * 1-3 months (+/- 1 week) * 6 months (+/- 2 weeks) * 12 months (+/- 1 month) * 2 years (+/- 3 month) * 3 years(+/- 3 month) Patients who have undergone a LAmbre explant should remain in the study and adhere to the above-mentioned follow-up time point until completion of 3-year follow-up period. After the patient has completed the 3-year follow-up assessments, the patient is considered to have completed the study. A study exit eCRF needs to be completed and the patient will receive routine care.

Device: LAmbre Occluder

Interventions

LAmbre Occluder DEVICE

All patients are implanted with Lifetech LAmbre occluder device.

Subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation with long-term sustainability are scheduled for interventional LAA closure.

You may qualify if:

• Patients must be at least 18 years of age;
• Patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure;
• Patient characteristics consistent with the corresponding IFU and sizing guidelines\*;
• Note: Choose a device that is 3-8mm larger than the landing zone diameter.
• The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Ethics Committee (EC);
• The patient agrees to comply with the requirements of the study including the 3-year follow-up.
• Warning: The device sizing is based on angiographic measurements.

You may not qualify if:

• Any contra-indication mentioned in the corresponding IFU\*;
• Note: In IFU, the Left Atrial Appendage Closure System is contraindicated for the following:
• Patients' LAA anatomy is not suitable for the REF of the device.
• Patients with intracardiac thrombus.
• Patients with active endocarditis or other infections causing bacteremia.
• Patients where the placement of the device would interfere with any intracardiac or intravascular structures.
• Patients with contraindications to X-ray and/or trans-esophageal echocardiographic examinations.
• Patients with known hypersensitivity to nickel.
• Currently participating in other investigational drug- or device studies;
• Patient who is pregnant, planning to become pregnant or breastfeeding;
• Patients cannot tolerate transoesophageal echocardiogram (TEE).

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead
• IQVIA Biotech: collaborator

Study Sites (26)

1001 - HKU Queen Mary Hospital

Hong Kong, 999077, China

Location

201 - Aarhus Universitetshospital

Aarhus, DK-8200, Denmark

Location

104 - Charité Campus Benjamin Franklin (CBF)

Berlin, 12203, Germany

Location

107 - Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

105 - UKB Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

111 - Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

114 - Facharztzentrum Dresden-Neustadt GbR

Dresden, 01099, Germany

Location

102 - Alfried Krupp Hospital Ruettenscheid

Essen, 45131, Germany

Location

101 - CVC CardioVasculäres Centrum Frankfurt

Frankfurt, 60389, Germany

Location

109 - Cardioangiologisches Centrum Bethanien (CCB)

Frankfurt, 60389, Germany

Location

108 - Universitätsklinikum Jena

Jena, 07747, Germany

Location

103 - Klinikum St. Georg gGmbH

Leipzig, 04129, Germany

Location

110 - Herzzentrum Leipzig (HZL)

Leipzig, 04289, Germany

Location

113 - Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

106 - Peter Osypka Herzzentrum

München, 81379, Germany

Location

301 - Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

Location

401 - Centro Cardiologico Monzino

Milan, 20122, Italy

Location

403 - ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

406 - Clinica Mediterranea S.P.A./Clinica Mediterranea - Ospedale e Centro Diagnostico

Napoli, 80122, Italy

Location

405 - La Struttura ASL Roma 2

Roma, 00157, Italy

Location

501 - Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego

Lodz, 91347, Poland

Location

603 - FundacióInstitut Hospital del Mar d'Investigacions Mèdiques (IMIM)

Barcelona, 08003, Spain

Location

602 - Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

601 - University Hospital of Salamanca/Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

801 - Sahlgrenska Universitetssjukhuset/Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

901 - Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Horst Sievert, Prof

  CVC CardioVasculäres Centrum Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: November 16, 2018
• Primary Completion: November 29, 2021
• Study Completion: September 30, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

PL (1); ES (3); CN (1); TH (1); IE (1); DE (13); IT (4); SE (1); DK (1)