Your session is about to expire
← Back to Search
Left Atrial Appendage Closure System
Left Atrial Appendage Closure for Atrial Fibrillation
N/A
Waitlist Available
Research Sponsored by Laminar, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject ≥18 years old
CHA2DS2-VASc score ≥ 2 in men and ≥ 3 in women
Must not have
Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium)
Circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Summary
This trial assesses a device to treat atrial fibrillation, so patients don't need to take anticoagulant meds.
Who is the study for?
This study is for adults with non-valvular atrial fibrillation who need an alternative to blood thinners. Candidates should have a CHA2DS2-VASc score of at least 2 (men) or 3 (women), be able to follow the study plan, and consent to participate. People can't join if they've had only one AF episode, severe heart issues, recent major health events like stroke or infection, are pregnant/nursing, or have conditions that prevent proper testing or use of the device.
What is being tested?
The trial tests the Laminar Left Atrial Appendage Closure System's safety and effectiveness in patients with atrial fibrillation who cannot take anticoagulants. It aims to provide a non-drug option for preventing strokes by sealing off a part of the heart where blood clots tend to form.
What are the potential side effects?
Potential side effects may include complications from general anesthesia, bleeding issues due to closure system placement, allergic reactions to device materials such as nickel or titanium, and possible risks associated with any invasive cardiac procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My stroke risk score is 2 or more if I'm a man, and 3 or more if I'm a woman.
Select...
I have a type of irregular heartbeat not caused by a heart valve issue.
Select...
I can follow the specific blood-thinning treatment plan after my procedure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not allergic to aspirin, heparin, nickel, or titanium.
Select...
I have a significant fluid buildup around my heart or symptoms of heart sac inflammation.
Select...
I have a complex plaque in my aorta.
Select...
I have severe heart failure.
Select...
I have had surgery or intervention for a heart valve problem or have a mechanical heart valve.
Select...
My heart's pumping ability is severely reduced.
Select...
I cannot have surgery that requires being put to sleep.
Select...
I have a tumor in my heart.
Select...
My kidney function is very low or I am on dialysis.
Select...
I currently have an infection in my blood.
Select...
I have a heart condition that requires closure of a hole in my heart.
Select...
I tested positive for COVID-19 within the last 10 days.
Select...
I need long-term blood thinners for a condition other than atrial fibrillation.
Select...
I have a bleeding disorder or a problem with blood clotting.
Select...
I have significant narrowing in my carotid artery, with or without stroke symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite Adverse Events
Composite of Ischemic Stroke or System Embolism
LAA Closure Rate
Secondary study objectives
Device-Related Thrombus
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Left Atrial Appendage Closure
2019
N/A
~20
Find a Location
Who is running the clinical trial?
Laminar, Inc.Lead Sponsor
3 Previous Clinical Trials
1,574 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
1,574 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an AF ablation in the last 90 days but may need one soon.I am 18 years old or older.My stroke risk score is 2 or more if I'm a man, and 3 or more if I'm a woman.I am not allergic to aspirin, heparin, nickel, or titanium.I am not pregnant or nursing and do not plan to become pregnant within a year.You have another serious illness or a history of substance abuse that may make it hard for you to follow the study's rules or take the required medication, or that could make it difficult to understand the study results.I have a significant fluid buildup around my heart or symptoms of heart sac inflammation.I have a complex plaque in my aorta.I have a type of irregular heartbeat not caused by a heart valve issue.I had a brief episode of AF due to a specific cause like surgery or thyroid issues.I have severe heart failure.I have had surgery or intervention for a heart valve problem or have a mechanical heart valve.My heart's pumping ability is severely reduced.I cannot have surgery that requires being put to sleep.I have a tumor in my heart.I have had or will have a surgery or procedure within 30 days before or 60 days after the index procedure.My kidney function is very low or I am on dialysis.I currently have an infection in my blood.You have a problem with your eyes that cannot be treated before the study.I have a heart condition that requires closure of a hole in my heart.My heart team has approved me for a procedure to close off a part of my heart.I can follow the specific blood-thinning treatment plan after my procedure.I have not had a heart attack or unstable chest pain in the last 90 days.I tested positive for COVID-19 within the last 10 days.I need long-term blood thinners for a condition other than atrial fibrillation.I have a bleeding disorder or a problem with blood clotting.You have very low or very high levels of platelets or white blood cells in your blood.You have a blood clot or abnormal blood flow in your heart that was seen on a test called TEE within 2 days before the procedure.You have a medical condition that prevents the use of a catheter-based system to deliver the implant.You have a medical condition that makes it difficult to get a clear picture of your heart using a transesophageal echocardiogram (TEE).I have not had a stroke or mini-stroke in the last 90 days.I need long-term blood thinner treatment but can't take it or need an alternative.You have a device in your body that could get in the way of the study procedure.I have significant narrowing in my carotid artery, with or without stroke symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger