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

Atrial Fibrillation Clinical Trial

— LISA  

Official title:

Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up: MULTI-CENTER, SINGLE-ARM, PROSPECTIVE, POST-MARKET STUDY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03666780
• Other study ID #: LA-PMCF-01
• Status: Active, not recruiting
• Start date: November 16, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Atrial fibrillation (AF) is the most common cardiac arrhythmia causing ischemic stroke. The CHA2DS2-VASc score was developed to estimate the stroke rate in patients with non-valvular AF, and high scores predict a raised annual stroke risk. The yearly stroke risks without treatment in patients with CHA2DS2-VASc Scores 2 and 9 are 2.2% and 15.2% respectively. For patients with increased stroke risk (CHA2DS2-VASc score ≧2), warfarin or other novel oral anticoagulants (NOAC) are recommended for stroke prevention.

Despite the effectiveness of current pharmacological therapies for stroke prevention in atrial fibrillation, around 20% of patients discontinue therapy - whether new oral anticoagulants (NOAC) or warfarin because of side effects and/or bleeding. In addition, warfarin needs to be dosed individually to target an international normalized ratio (INR) of 2-3 for striking an optimal balance between bleeding and ischemic stroke events. This, combined with drug-drug interaction that occurs with both NOACs and warfarin, results in inadequate stroke protection in a substantial portion of AF patients. The LAA is the source of 90% of cardiac emboli attributed to stroke events. This is a windsock-like structure on the lateral border of the left atrium with internal trabeculations, and being a confined space is prone to blood stasis and thrombus formation.

Currently, there are surgical, epicardial, and percutaneous techniques for occluding this structure in order to reduce stroke in AF patients who cannot take long-term oral anticoagulants, and the percutaneous route is intuitively the most attractive given its relative non-invasiveness. The two devices in most widespread use for percutaneous LAA closure worldwide are the Watchman (Boston Scientific, Natick, MA, USA) and the Amplatzer Cardiac Plug (ACP) (Abbott, IL, CA USA). However, both devices have limitations including the need for relatively large delivery sheaths (9-14 French) and limited recapture and repositioning capabilities.

LAmbre™ LAA Closure System (Lifetech Scientific, Shenzhen, China) is a novel self-expanding LAA occluder constructed from a nitinol mesh and polyester membranes and consists of an umbrella and a cover connected by a short central waist. The device is delivered by an 8-10 French sheath and has full recapture and repositioning capabilities. LAmbre™ LAA Closure System received the CE mark in June 2016.

This PMCF study will be carried out following the CE mark of the LAmbre™ LAA Closure System and is intended to confirm the effectiveness and safety of the LAmbre™ LAA Closure System.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 30, 2024
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must be at least 18 years of age;

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

3. Patient characteristics consistent with the corresponding IFU and sizing guidelines*;

• Note: Choose a device that is 3-8mm larger than the landing zone diameter.

4. 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);

5. 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.

Exclusion Criteria:

1. Any contra-indication mentioned in the corresponding IFU*;

• Note: In IFU, the Left Atrial Appendage Closure System is contraindicated for the following:

1. Patients' LAA anatomy is not suitable for the REF of the device.

2. Patients with intracardiac thrombus.

3. Patients with active endocarditis or other infections causing bacteremia.

4. Patients where the placement of the device would interfere with any intracardiac or intravascular structures.

5. Patients with contraindications to X-ray and/or trans-esophageal echocardiographic examinations.

6. Patients with known hypersensitivity to nickel.

2. Currently participating in other investigational drug- or device studies;

3. Patient who is pregnant, planning to become pregnant or breastfeeding;

4. Patients cannot tolerate transoesophageal echocardiogram (TEE).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• LAmbre Occluder
All patients are implanted with Lifetech LAmbre occluder device.

Locations

Country	Name	City	State
China	1001 - HKU Queen Mary Hospital	Hong Kong
Denmark	201 - Aarhus Universitetshospital	Aarhus
Germany	104 - Charité Campus Benjamin Franklin (CBF)	Berlin
Germany	107 - Charité Campus Virchow-Klinikum	Berlin
Germany	105 - UKB Universitätsklinikum Bonn	Bonn
Germany	111 - Klinikum Coburg GmbH	Coburg
Germany	114 - Facharztzentrum Dresden-Neustadt GbR	Dresden
Germany	102 - Alfried Krupp Hospital Ruettenscheid	Essen
Germany	101 - CVC CardioVasculäres Centrum Frankfurt	Frankfurt
Germany	109 - Cardioangiologisches Centrum Bethanien (CCB)	Frankfurt
Germany	108 - Universitätsklinikum Jena	Jena
Germany	103 - Klinikum St. Georg gGmbH	Leipzig
Germany	110 - Herzzentrum Leipzig (HZL)	Leipzig
Germany	113 - Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	106 - Peter Osypka Herzzentrum	München
Ireland	301 - Mater Misericordiae University Hospital	Dublin
Italy	401 - Centro Cardiologico Monzino	Milan
Italy	403 - ASST Grande Ospedale Metropolitano Niguarda	Milan
Italy	406 - Clinica Mediterranea S.P.A./Clinica Mediterranea - Ospedale e Centro Diagnostico	Napoli
Italy	405 - La Struttura ASL Roma 2	Roma
Poland	501 - Wojewódzki Specjalistyczny Szpital im. dr. Wl. Bieganskiego	Lódz
Spain	602 - Hospital Clínic de Barcelona	Barcelona
Spain	603 - Fundacio´Institut Hospital del Mar d'Investigacions Me`diques (IMIM)	Barcelona
Spain	601 - University Hospital of Salamanca/Hospital Clínico Universitario de Salamanca	Salamanca
Sweden	801 - Sahlgrenska Universitetssjukhuset/Sahlgrenska University Hospital	Göteborg
Thailand	901 - Faculty of Medicine Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.	IQVIA Biotech

Countries where clinical trial is conducted

China,  Denmark,  Germany,  Ireland,  Italy,  Poland,  Spain,  Sweden,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Incidence of stroke or systemic embolism or death through 3 years post-implantation.	Incidence of stroke or systemic embolism or death through 3 years post-implantation.	From attempted procedure to 3 years post-implantation
Secondary	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.	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
Secondary	Device or procedure-related Serious Adverse Events (SAEs) from attempted procedure through 3 years 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
Secondary	All SAEs (death included) from attempted procedure through 3 years post-implantation.	All SAEs (death included) from attempted procedure through 3 years post-implantation.	From attempted procedure to 3 years post-implantation