Non-valvular Atrial FibrillationNCT04559243
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
An observational study of Non-valvular Atrial Fibrillation and Embolic Stroke, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 5 sites in China.
Trial summary
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation, Embolic Stroke
- What is being tested?
- Transthoracic Echocardiography
- How many people
- 579 participants
- Where
- 5 sitesChina
- Study dates
- 12 Nov 2020to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 atrial fibrillation and previous AF-related embolic events
Who may be able to join
- Age ≥ 18 years, male or female;
- Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol;
- Indications for left atrial appendage closure;
- Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;
- HAS-BLED bleeding risk score ≥ 3 points;
- Not suitable for long-term oral anticoagulant therapy;
- Poor compliance with oral anticoagulants;
- CHA2DS2-VASc score ≧ 2 points;
Who cannot join
- Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)
- Initial AF, reversible AF with clear cause
- Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus
- ST elevation myocardial infarction, ≤ 3 months
- Grade-IV of Cardiac Function (NYHA)
- Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants
Show all 11Show fewer
- Pregnant or with plan of pregnancy during the study
- Participation in another drug or medical device clinical trial or study that has not been completed
- Experience new stroke or TI within 30 days or major bleeding events within 14 days
- Contraindication to LAA closure or deemed unsuitable for study participation by the investigator
- Had a definite thromboembolic event
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Zhong Jingquan, Doctor, 18560086597, 18560086597@163.com
Zhong Jingquan, Doctor
- Recruiting
Sichuan Mianyang 404 Hospital
Mianyang, Sichuan, 621000
Zhang Dayong, Doctor, 13890135264, 504082447@qq.com
Zhang Dayong, Doctor
- Recruiting
Shanghai Songjiang District Central Hospital
Shanghai, Shanghai Municipality, 200000
Zhao Wenbiao, Doctor, 18918288026
Zhao Wenbiao, Doctor
- Recruiting
The first Affiliated Hospital of WMU
Wenzhou, Zhejiang, 325600
Huang Weijian, Doctor, 13806691086, weijianhuang69@126.com
Huang Weijian, Doctor
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325600
Li Yuechun, Doctor, 13616776960, liyuechun1980@sina.com
Li Yuechun, Doctor
About this study
Official title: A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.
Read the detailed description
Study Population Patients with non-valvular atrial fibrillation and previous AF-related embolic events Purpose To assess the feasibility and safety of percutaneous LAA closure as secondary prevention for patients with non-valvular atrial fibrillation (NVAF) and previous atrial fibrillation (AF) related embolic events (including ischemic stroke, transient ischemic attack (TIA), and systemic embolism).
- Conditions
- Non-valvular Atrial Fibrillation, Embolic Stroke
- Being tested
- Transthoracic Echocardiography
- Keywords
- AF-related embolic events, non-valvular atrial fibrillation, Left Atrial Appendage Closure
- Medical subject headings
- Embolic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyDiagnostic test
Also called Transesophageal Echocardiography
After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
Ischemic stroke, systemic embolism, and cardiac death events
Measured: 12 months
Incidence of major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells) at 12 months after operation
Bleeding events
Measured: 12 months
Secondary outcomes (7)
Surgical success rate
Surgical success
Measured: 24 months
Success rate of LAA closure at 3 months after operation
Successful LAA closure was defined as a residual shunt ≤ 3 mm by TEE or ICE after implantation of the LAA occluder.
Measured: 3 months
The composite endpoint of new ischemic stroke, systemic embolism and cardiac death at 7 months after operation or before discharge and at 1, 3, 6 and 24 months after operation
Ischemic stroke, systemic embolism, and cardiac death events
Measured: 24 months
(4)Perioperative (7 days after operation or before discharge) surgery-related complications
7 days after operation or pre-discharge procedure-related complications include but are not limited to stroke (ischemic and hemorrhagic stroke), systemic embolism, allergic reaction, gas embolism, pericardial effusion/cardiac tamponade requiring intervention, occluder detachment, occluder thrombosis (DRT), minor bleeding events (including but not limited to puncture site hematoma, non-major bleeding events), infection, arrhythmia, damage to blood vessels or organs on the implantation path and adjacent organs
Measured: 7 days
Procedure-related complications during follow-up
Follow-up at 1, 3, 6, 12 and 24 months after operation for procedure-related complications, including all-cause death, stroke (ischemic and hemorrhagic stroke), cardiac perforation, pericardial effusion/cardiac tamponade requiring intervention, major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells), occluder thrombosis (DRT), infection, systemic embolism, allergic reaction, arrhythmia, and other serious cardiovascular events requiring intervention or surgical treatment
Measured: 24 months
Occluder defects during operation and in the 3rd month after operation
Including but not limited: Occluder displacement, Occluder detachment, Occluder breakage, Occluder damage, etc
Measured: 3 months
Incidence rate of severe adverse events within 24 months after operation
including but not limited to all-cause death, events requiring hospitalization or prolongation of hospitalization, severe endocarditis requiring surgery, pericarditis, cardiac perforation, valvular injury, vascular or gas embolism events, occluder detachment/displacement, occluder fracture, occluder thrombosis (DRT), stroke events
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 posted22 Sep 2020
- Study start12 Nov 2020
- Primary completionNov 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 579 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chenyang Jiang, Doctor, Principal investigator, Sir Run Run Shaw HospitalJinhua Zhang, Doctor, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559243
- Sponsor's protocol ID
- LAAC-01
- Status last verified
- Nov 2022
- First submitted
- 14 Sep 2020
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04559243
- Acronym / sponsor ID
- LAAC-01
- Conditions
- Non-valvular Atrial Fibrillation, Embolic Stroke
- Keywords
- AF-related embolic events, non-valvular atrial fibrillation, Left Atrial Appendage Closure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 579 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Sep 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.
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.
Detailed description
Study Population Patients with non-valvular atrial fibrillation and previous AF-related embolic events Purpose To assess the feasibility and safety of percutaneous LAA closure as secondary prevention for patients with non-valvular atrial fibrillation (NVAF) and previous atrial fibrillation (AF) related embolic events (including ischemic stroke, transient ischemic attack (TIA), and systemic embolism).
Study design
- Observational model
- Ecologic or community
- 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 atrial fibrillation and previous AF-related embolic events
Key inclusion criteria (8 listed)
- Age ≥ 18 years, male or female;
- Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol;
- Indications for left atrial appendage closure;
- Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;
Key exclusion criteria (11 listed)
- Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)
- Initial AF, reversible AF with clear cause
- Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus
- ST elevation myocardial infarction, ≤ 3 months
- Grade-IV of Cardiac Function (NYHA)
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 |
|---|---|---|
| Transthoracic EchocardiographyAlso: Transesophageal EchocardiographyAfter the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital. | Diagnostic test | – |
Primary outcome
Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
Time frame: 12 months
Ischemic stroke, systemic embolism, and cardiac death events
Incidence of major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells) at 12 months after operation
Time frame: 12 months
Bleeding events
7 secondary outcomes
Surgical success rate
Time frame: 24 months
Success rate of LAA closure at 3 months after operation
Time frame: 3 months
The composite endpoint of new ischemic stroke, systemic embolism and cardiac death at 7 months after operation or before discharge and at 1, 3, 6 and 24 months after operation
Time frame: 24 months
(4)Perioperative (7 days after operation or before discharge) surgery-related complications
Time frame: 7 days
Procedure-related complications during follow-up
Time frame: 24 months
Occluder defects during operation and in the 3rd month after operation
Time frame: 3 months
Incidence rate of severe adverse events within 24 months after operation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Non-valvular Atrial Fibrillation
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CHAMPION-AF Clinical Trial
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Vortosiran in Atrial Fibrillation
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WATCHMAN FLX Pro European Registry
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LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation
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.
Chenyang Jiang, Doctor principal investigator
Sir Run Run Shaw Hospital
Jinhua Zhang, Doctor principal investigator
Sir Run Run Shaw Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation and Embolic Stroke, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 5 sites in China.
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 8 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: looking for participants now, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenyang Jiang, Doctor (8613857190051, panshangming@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation (time frame: 12 months). 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 19 Dec 2022.