Atrial FibrillationNCT04807283
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
A study testing Left Atrial Appendage Closure in people with Atrial Fibrillation, run by Laminar, Inc. at 4 sites in 2 countries.
Trial summary
The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA). 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?
- Left Atrial Appendage Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 5 Mar 2021to Dec 2023
- 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
- 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
- 2. Subject must be ≥18 years of age.
- 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater.
- 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
- 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
- 6. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.
Who cannot join
- 1. Subject who requires anticoagulation for a condition other than AF.
- 2. Subject with a New York Heart Association (NYHA) classification equal to IV.
- 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
- 4. Subject with valvular disease.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Georgia2 sites
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi
Tbilisi Heart and Vascular Clinic
Tbilisi
Paraguay2 sites
Sanatorio Italiano Hospital
Asunción
Hospital de Clinicas San Lorenzo, National University
San Lorenzo
About this study
Official title: A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).
- Conditions
- Atrial Fibrillation
- Being tested
- Left Atrial Appendage Closure
- Keywords
- Left Atrial Appendage Closure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage ClosureDevice
Also called Left Atrial Appendage Occlusion
Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Left Atrial Appendage Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device or procedure related serious adverse events
Measured: 7 days
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
Measured: 45 days
Secondary outcomes (1)
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism
Measured: 45 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start5 Mar 2021
- Primary completion26 Nov 2021
- Study completionDec 2023 (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.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laminar, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807283
- Sponsor's protocol ID
- CL-0017
- Status last verified
- Oct 2023
- First submitted
- 17 Mar 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04807283
- Acronym / sponsor ID
- CL-0017
- Conditions
- Atrial Fibrillation
- Keywords
- Left Atrial Appendage Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Laminar, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Mar 2021 (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 objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Left Atrial Appendage Closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
- 2. Subject must be ≥18 years of age.
- 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater.
- 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
- 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
Key exclusion criteria (4 listed)
- 1. Subject who requires anticoagulation for a condition other than AF.
- 2. Subject with a New York Heart Association (NYHA) classification equal to IV.
- 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
- 4. Subject with valvular disease.
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 |
|---|---|---|
| Left Atrial Appendage ClosureAlso: Left Atrial Appendage OcclusionClosure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF | Device | Treatment |
Primary outcome
Freedom from device or procedure related serious adverse events
Time frame: 7 days
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
Time frame: 45 days
1 secondary outcome
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism
Time frame: 45 days and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Appendage Closure in people with Atrial Fibrillation, run by Laminar, Inc. at 4 sites in 2 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 6 inclusion and 4 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia, Paraguay. 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?
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?
Freedom from device or procedure related serious adverse events (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 3 Oct 2023.