Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry

NCT ID: NCT04307927

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-14
• Study Completion Date: 2025-12-31

Brief Summary

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

Detailed Description

Detailed 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 score 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) 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 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.

LAmbreTM 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. LAmbreTM LAA Closure System received the CE mark in June 2016.

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

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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*; 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 requirements of the study including the 24 months follow- up.

Exclusion Criteria

• 1. Any contra-indication mentioned in the corresponding IFU*; 2. Currently participating in other investigational drug- or device studies; 3. Patient who is pregnant, planning to become pregnant, or breast feeding; 4. Patients cannot tolerate transoesophageal echocardiogram (TEE).

• Note: In IFU, the Left Atrial Appendage Closure System is contraindicated for the following: • Patients' LAA anatomy not suitable for the REF of the device.

• Patients' with intracardiac thrombus.
• Patients with active endocarditis or other infections causing bacteremia.
• Patients where 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiangtao Yu, Professor

Role: PRINCIPAL_INVESTIGATOR

Katholisches Klinikum Koblenz ·Montabaur

Locations

Katholisches Klinikum Koblenz ·Montabaur

Koblenz, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Yun Li

Role: CONTACT

liyun@lifetechmed.com

+86 13534247025

Facility Contacts

Jiangtao Yu, Professor

Role: primary

Other Identifiers

LA-PMCF-02

Identifier Type: -

Identifier Source: org_study_id