Atrial FibrillationNCT03122028
Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
A study testing LAA closure system in people with Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd..
Trial summary
The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal and transthoracic echocardiography. 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?
- LAA closure system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2013to 9 Nov 2016
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years
- Patients scheduled for interventional closure of the left atrial appendage (LAA) due to a high thromboembolic risk and cannot be treated with anticoagulation.
- Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent nonvalvular Atrial Fibrilation (AF)
- CHA2DS2 -VASC score 2 or higher
- Eligible for clopidogrel and aspirin
- Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits
Who cannot join
- Presence of rheumatic, degenerative or congenital valvular heart diseases
- Presence of rheumatic, degenerative or congenital valvular heart diseases
- The diameter of left atrium ≥65 mm
- LAA Ostium < 12mm or > 30 mm
- Prior surgical removal of Left atrium
- Prior heart transplant
Show all 30Show fewer
- Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%)
- Recent or acute myocardial infarction (MI) or unstable angina (recent is defined as within 3 months of implant date)
- Decompensated heart failure (NYHA grade III-IV)
- Patients have an electrophysiological ablation procedure planned within 30 days of potential the LAmbreTM Left Atrial Appendage Closure System implant date
- Patients have a planned electrophysiologic 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System
- Patients have a planned cardioversion 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System
- Patients with a history of heart valve replacement operation with an mechanical prosthesis
- History of stroke or Transient Ischemic Attack (TIA) within 30 days
- Have thrombocytopenia (platelet ≤ 100.000 platelets per microliter (mcL))
- Heart rate in rest > 110 beats per minute (BPM)
- A single episode of transient atrial fibrillation
- Pericardial effusion > 5mm pre-procedural
- Presence of active sepsis or endocarditis
- Cardiac tumors or other malignancy with estimated life expectancy less than 2 years
- Patients who are pregnant, breastfeeding, or desires to become pregnant during the course of the study
- Participation in the other investigational trials in which the primary endpoint is not met yet
- Subject dependency of the Sponsor, of the institution in which the trail is conducted, or of the investigator
- Investigator expectation that the patient will not be able to complete the trial according to the requirements
- A known allergy to nitinol Esophageal ultrasonic exclusion criteria
- LVEF ≤ 30 %
- Presence of thrombus in the left atrial appendage (LAA)
- Patent Foramen Ovale (PFO) with history of paradoxical embolism
- Mitral valve stenosis (Mitral valve area ≤ 2 cm2)
- Presence of complex aortic plaque (≥4mm) in ascending aorta
About this study
Official title: A Prospective, Non-Randomized, Multi-Center, Open-Label, Non-Comparative, Interventional Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal and transthoracic echocardiography.
The conducted LA-EU-01 study was a prospective, non-randomized, multi-center, open-label, non-comparative, interventional clinical investigation with the participation of two clinical centers in Germany and the inclusion of 61 subjects.
Read more
Participating subjects were patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and scheduled for interventional closure of the left atrial appendage who could not be treated with anticoagulation.
After the procedure of implantation of the LAmbreTM Left Atrial Appendage Closure System, patients underwent a first follow up assessment prior to hospital discharge then at 30 days, 6 and 12 months.
- Conditions
- Atrial Fibrillation
- Being tested
- LAA closure system
- Keywords
- LAmbre
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAA closure systemDevice
Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and cannot be treated with anticoagulation and scheduled for interventional left atrial appendage closure.
| Study group | Role | What they receive |
|---|---|---|
| LAmbre closure system | Experimental | Not described Receives: Device: LAA closure system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Absence of device or procedure related serious adverse events at 6 months after device implantation
Measured: 6 months
Stable device placement
Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
Measured: 6 months
Residual jet flow
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 implant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start5 Nov 2013
- Primary completion9 Mar 2016
- Study completion9 Nov 2016
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, Principal investigator, The Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122028
- Sponsor's protocol ID
- LA-EU-01
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Multi-Center, Open-Label, Non-Comparative, Interventional Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
- ClinicalTrials.gov ID
- NCT03122028
- Acronym / sponsor ID
- LA-EU-01
- Conditions
- Atrial Fibrillation
- Keywords
- LAmbre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 9 Mar 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 20 Apr 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 aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal and transthoracic echocardiography.
The conducted LA-EU-01 study was a prospective, non-randomized, multi-center, open-label, non-comparative, interventional clinical investigation with the participation of two clinical centers in Germany and the inclusion of 61 subjects.
Participating subjects were patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and scheduled for interventional closure of the left atrial appendage who could not be treated with anticoagulation.
After the procedure of implantation of the LAmbreTM Left Atrial Appendage Closure System, patients underwent a first follow up assessment prior to hospital discharge then at 30 days, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAmbre closure system | Experimental | Device: LAA closure system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Patients scheduled for interventional closure of the left atrial appendage (LAA) due to a high thromboembolic risk and cannot be treated with anticoagulation.
- Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent nonvalvular Atrial Fibrilation (AF)
- CHA2DS2 -VASC score 2 or higher
- Eligible for clopidogrel and aspirin
Key exclusion criteria (30 listed)
- Presence of rheumatic, degenerative or congenital valvular heart diseases
- Presence of rheumatic, degenerative or congenital valvular heart diseases
- The diameter of left atrium ≥65 mm
- LAA Ostium < 12mm or > 30 mm
- Prior surgical removal of Left atrium
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 systemPatients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and cannot be treated with anticoagulation and scheduled for interventional left atrial appendage closure. | Device | LAmbre closure system |
Primary outcome
Serious adverse events
Time frame: 6 months
Absence of device or procedure related serious adverse events at 6 months after device implantation
Stable device placement
Time frame: 6 months
Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
Residual jet flow
Time frame: 6 months
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 implant
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 21 Apr 2017.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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 principal investigator
The Cardiovascular Center
Questions about this trial
What is this clinical trial studying?
A study testing LAA closure system in people with Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd..
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 6 inclusion and 30 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 21 Apr 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?
Serious adverse events (time frame: 6 months). The study lists 3 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 21 Apr 2017.