Lifetech LAmbre Left Atrial Appendage Closure System Post-Market Registry

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    100
  • sponsor
    Lifetech Scientific (Shenzhen) Co., Ltd.
Updated on 21 May 2021
fibrillation
permanent atrial fibrillation
left atrial appendage closure

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.

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.

Details
Condition Atrial Fibrillation, Dysrhythmia, Atrial Fibrillation (Pediatric), Arrhythmia
Clinical Study IdentifierNCT04307927
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
Last Modified on21 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. 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

\. 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note