Atrial FibrillationNCT03147391
Left Atrial Appendage Closure With the LAmbre
An observational study of Atrial Fibrillation and Left Atrial Appendage Closure, run by Shanghai 10th People's Hospital.
Trial summary
The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Closure, Stroke
- What is being tested?
- LAA closure with LAmbre
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2014to 1 May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The aim of this retrospective study was to evaluate the long-term follow-up results associated with left atrial appendage closure (LAAC) with the LAmbre (Lifetech Scientific Corp., Shenzhen, China) in patients with nonvalvular atrial fibrillation (NVAF).
Who may be able to join
- Patient is ≥18 years of age;
- Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
- CHADS2-VAS score 2 or higher;
- Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
- Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.
Who cannot join
- A. Clinical exclusion criteria
- Presence of rheumatic, degenerative or congenital valvular heart diseases,
- The diameter of left atrial ≥65 mm;
- LAA size < 12mm or > 30 mm
- Left atrium has been removed;
- Heart transplantation patients;
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- Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
- Acute myocardial infarction or unstable angina;
- Decompensated heart failure (New York Heart Association functional class III-IV);
- Recent myocardial infarction (< 3 months);
- Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant
- The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
- Patient who after artificial mechanical heart valve replacement operation;
- Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
- Presence of complex aortic plaque(4mm) in ascending aorta;
- Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
- Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb<10g/dl）;
- Women who is pregnancy or plan to pregnancy during the trial period;
- Presence of active sepsis or endocarditis;
- Patient participated in the other trials;
- The investigators expect the patient not be able to complete the trial according to requirements.
- Esophageal ultrasonic exclusion criteria
- LVEF≤30%;
- Presence of left atrial appendage thrombus;
- High risk PFO patients(presence of atrial septal aneurysm);
- Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
- Have obvious and unexplained pericardial effusion(≥4 cm2).
- Presence of complex aortic plague(≥4 mm) in ascending aorta.
About this study
Official title: Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation: a Single-center, Retrospective, Long-term Real-world Study
The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.
Read the detailed description
The study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (LAA) closure using the LAmbre (Lifetech Scientific Co., Ltd., Shenzhen, China) in our center from April 2014 to November 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (TEE) examination. The average followup was 2-years.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Stroke
- Being tested
- LAA closure with LAmbre
- Keywords
- Atrial Fibrillation, Left Atrial Appendage Closure, LAmbre device, Stroke
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAA closure with LAmbreDevice
Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation
| Study group | Role | What they receive |
|---|---|---|
| LAA closure with LAmbre | The patients with atrial fibrillation who received left atrial appendage (LAA) closure using the LAmbre device in our center from April 2014 to November 2015. Receives: Device: LAA closure with LAmbre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke
Ischemic stroke
Measured: up to 5 years
Secondary outcomes (2)
The composite safety and efficacy end-points
all-cause death, stroke, major bleeding, thromboembolism, device related severe complications
Measured: up to 5 years
Successful sealing of the LAA
successful sealing around the device at the LAA orifice (residual jet flow of < 5 mm) as measured by transesophageal echocardiogram (TEE) at 6 months after device implantation
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start14 Apr 2014
- Primary completion30 Nov 2016
- Study completion1 May 2017
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, MD, PHD, Study director, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147391
- Sponsor's protocol ID
- LAmbre in real world
- Status last verified
- May 2017
- First submitted
- 9 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation: a Single-center, Retrospective, Long-term Real-world Study
- ClinicalTrials.gov ID
- NCT03147391
- Acronym / sponsor ID
- LAmbre in real world
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Stroke
- Keywords
- Atrial Fibrillation, Left Atrial Appendage Closure, LAmbre device, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Study start
- 14 Apr 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 10 May 2017 (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.
The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.
Detailed description
The study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (LAA) closure using the LAmbre (Lifetech Scientific Co., Ltd., Shenzhen, China) in our center from April 2014 to November 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (TEE) examination. The average followup was 2-years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAA closure with LAmbre | – | Device: LAA closure with LAmbreThe patients with atrial fibrillation who received left atrial appendage (LAA) closure using the LAmbre device in our center from April 2014 to November 2015. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The aim of this retrospective study was to evaluate the long-term follow-up results associated with left atrial appendage closure (LAAC) with the LAmbre (Lifetech Scientific Corp., Shenzhen, China) in patients with nonvalvular atrial fibrillation (NVAF).
Key inclusion criteria (5 listed)
- Patient is ≥18 years of age;
- Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
- CHADS2-VAS score 2 or higher;
- Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
- Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.
Key exclusion criteria (28 listed)
- A. Clinical exclusion criteria
- Presence of rheumatic, degenerative or congenital valvular heart diseases,
- The diameter of left atrial ≥65 mm;
- LAA size < 12mm or > 30 mm
- Left atrium has been removed;
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 |
|---|---|---|
| LAA closure with LAmbrePercutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation | Device | LAA closure with LAmbre |
Primary outcome
Ischemic stroke
Time frame: up to 5 years
Ischemic stroke
2 secondary outcomes
The composite safety and efficacy end-points
Time frame: up to 5 years
Successful sealing of the LAA
Time frame: up to 5 years
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 10 May 2017.
- Individual participant dataSharing planned: No
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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.
Yawei Xu, MD, PHD study director
Shanghai 10th People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Left Atrial Appendage Closure, run by Shanghai 10th People's Hospital.
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 5 inclusion and 28 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Ischemic stroke (time frame: up to 5 years). 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 10 May 2017.