Atrial FibrillationLISANCT03666780
Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study
An observational study of Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 26 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LAmbre Occluder
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 26 sitesin 9 countries
- Study dates
- 16 Nov 2018to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation with long-term sustainability are scheduled for interventional LAA closure.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
26 sites in 9 countries.
26 sites in 9 countries
Germany13 sites
104 - Charité Campus Benjamin Franklin (CBF)
Berlin, 12203
107 - Charité Campus Virchow-Klinikum
Berlin, 13353
105 - UKB Universitätsklinikum Bonn
Bonn, 53127
111 - Klinikum Coburg GmbH
Coburg, 96450
114 - Facharztzentrum Dresden-Neustadt GbR
Dresden, 01099
102 - Alfried Krupp Hospital Ruettenscheid
Essen, 45131
101 - CVC CardioVasculäres Centrum Frankfurt
Frankfurt, 60389
109 - Cardioangiologisches Centrum Bethanien (CCB)
Frankfurt, 60389
108 - Universitätsklinikum Jena
Jena, 07747
103 - Klinikum St. Georg gGmbH
Leipzig, 04129
110 - Herzzentrum Leipzig (HZL)
Leipzig, 04289
113 - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
106 - Peter Osypka Herzzentrum
München, 81379
Italy4 sites
401 - Centro Cardiologico Monzino
Milan, 20122
403 - ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
406 - Clinica Mediterranea S.P.A./Clinica Mediterranea - Ospedale e Centro Diagnostico
Naples, 80122
405 - La Struttura ASL Roma 2
Roma, 00157
Spain3 sites
603 - FundacióInstitut Hospital del Mar d'Investigacions Mèdiques (IMIM)
Barcelona, 08003
602 - Hospital Clínic de Barcelona
Barcelona, 08036
601 - University Hospital of Salamanca/Hospital Clínico Universitario de Salamanca
Salamanca, 37007
Poland1 site
501 - Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego
Lodz, 91347
Sweden1 site
801 - Sahlgrenska Universitetssjukhuset/Sahlgrenska University Hospital
Gothenburg, 41345
Thailand1 site
901 - Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400
About this study
Official title: Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up: MULTI-CENTER, SINGLE-ARM, PROSPECTIVE, POST-MARKET STUDY
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.
Read the 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 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.
- Conditions
- Atrial Fibrillation
- Being tested
- LAmbre Occluder
- Keywords
- Left Atrial Appendage Occluder, LAmbre, Lifetech LAA, Lifetech LAmbre, LT LAA, Left Atrial Appendage
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAmbre OccluderDevice
All patients are implanted with Lifetech LAmbre occluder device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LAmbre Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At procedure.
Secondary outcomes (4)
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.
Measured: 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.
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.
Measured: 1-3 months, 6 months post-implantation
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.
Measured: From attempted procedure to 3 years post-implantation
All SAEs (death included) from attempted procedure through 3 years post-implantation.
All SAEs (death included) from attempted procedure through 3 years post-implantation.
Measured: From attempted procedure to 3 years post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start16 Nov 2018
- Primary completion29 Nov 2021
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Biotech
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, Prof, Principal investigator, CVC CardioVasculäres Centrum Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666780
- Sponsor's protocol ID
- LA-PMCF-01
- Acronym
- LISA
- Status last verified
- Jul 2025
- First submitted
- 10 Sep 2018
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up: MULTI-CENTER, SINGLE-ARM, PROSPECTIVE, POST-MARKET STUDY
- ClinicalTrials.gov ID
- NCT03666780
- Acronym / sponsor ID
- LISA / LA-PMCF-01
- Conditions
- Atrial Fibrillation
- Keywords
- Left Atrial Appendage Occluder, LAmbre, Lifetech LAA, Lifetech LAmbre, LT LAA, Left Atrial Appendage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Biotech
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject | – | Device: LAmbre OccluderAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation with long-term sustainability are scheduled for interventional LAA closure.
Key inclusion criteria (7 listed)
- 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*;
- 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.
Key exclusion criteria (11 listed)
- Any contra-indication mentioned in the corresponding IFU*;
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAmbre OccluderAll patients are implanted with Lifetech LAmbre occluder device. | Device | Subject |
Primary outcome
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);
Time frame: Within 7 days post-procedure.
Peri-procedure defined as within 7 days of the procedure.
Implant success.
Time frame: At procedure.
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).
4 secondary outcomes
Incidence of stroke or systemic embolism or death through 3 years post-implantation.
Time frame: 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.
Time frame: 1-3 months, 6 months post-implantation
Device or procedure-related Serious Adverse Events (SAEs) from attempted procedure through 3 years post-implantation
Time frame: From attempted procedure to 3 years post-implantation
All SAEs (death included) from attempted procedure through 3 years post-implantation.
Time frame: From attempted procedure to 3 years post-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Sievert, Prof principal investigator
CVC CardioVasculäres Centrum Frankfurt
26 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 26 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Italy, Spain, China, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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); (time frame: Within 7 days post-procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.