Atrial FibrillationNCT04307927
Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry
An observational study of Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 14 Mar 2020to 31 Dec 2025
- 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 paroxymal, persistent or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Katholisches Klinikum Koblenz ·Montabaur
Koblenz, 56073
Jiangtao Yu, Professor
About this study
Official title: Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry Single-center, Single-arm, Prospective, Post-market Registry
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.
Read the 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
- Keywords
- Left atrial appendage occluder
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
1.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: 7 days
Implant success
Implant success defined as correct positioning and release of the occluder device into the proper anatomical location. Correct positioning is assessed as absence of major residual jet flow (>5mm) into the LAA closure with the device evaluated by transesophageal echocardiogram (TEE).
Measured: 1 day
Secondary outcomes (5)
Incidence of stroke or systemic embolism or death through 24 months post implantation
Incidence of stroke or systemic embolism or death through 24 months post
Measured: 24 months
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 24 months post implantation
Device or procedure related Serious Adverse Events (SAEs) from attempted procedure through 24 months post implantation
Measured: 24 months
All SAEs (death included) from attempted procedure through 24 months post implantation
All SAEs (death included) from attempted procedure through 24 months post implantation
Measured: 24 months
Incidence of bleeding event through 24 months post implantation.
Incidence of bleeding event through 24 months post implantation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start14 Mar 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiangtao Yu, Professor, Principal investigator, Katholisches Klinikum Koblenz ·Montabaur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307927
- Sponsor's protocol ID
- LA-PMCF-02
- Status last verified
- Nov 2022
- First submitted
- 12 Mar 2020
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry Single-center, Single-arm, Prospective, Post-market Registry
- ClinicalTrials.gov ID
- NCT04307927
- Acronym / sponsor ID
- LA-PMCF-02
- Conditions
- Atrial Fibrillation
- Keywords
- Left atrial appendage occluder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Mar 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 paroxymal, persistent or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1.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: 7 days
Peri-procedure defined as within 7 days of the procedure.
Implant success
Time frame: 1 day
Implant success defined as correct positioning and release of the occluder device into the proper anatomical location. Correct positioning is assessed as absence of major residual jet flow (>5mm) into the LAA closure with the device evaluated by transesophageal echocardiogram (TEE).
5 secondary outcomes
Incidence of stroke or systemic embolism or death through 24 months post implantation
Time frame: 24 months
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 24 months post implantation
Time frame: 24 months
All SAEs (death included) from attempted procedure through 24 months post implantation
Time frame: 24 months
Incidence of bleeding event through 24 months post implantation.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
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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.
Jiangtao Yu, Professor principal investigator
Katholisches Klinikum Koblenz ·Montabaur
1 site in 1 country: 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 1 site in Germany.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Li (+86 13534247025, liyun@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.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: 7 days). 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 29 Nov 2022.