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Ligation Device
Left Atrial Appendage Closure Device for Atrial Fibrillation (LASSO-AF Trial)
N/A
Waitlist Available
Led By Sheldon Singh, MD
Research Sponsored by Aegis Medical Innovations
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented non-valvular atrial fibrillation
Age >=18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline to 6-months and 1-year from procedure
Awards & highlights
LASSO-AF Trial Summary
This trial is testing a device to safely access and close off the left atrial appendage in people with atrial fibrillation. Up to 30 people will be enrolled at 8 centers in Canada and the US.
Who is the study for?
This trial is for adults with non-valvular atrial fibrillation at risk of stroke, needing a non-drug alternative to oral anticoagulants. Candidates must be willing to consent and follow study procedures, able to take antiplatelet therapy post-procedure, and have a CHA2DS2-VASc score of ≥2. Exclusions include recent heart attack or surgery, certain heart conditions or diseases, life expectancy under 24 months, pregnancy, drug/alcohol addiction.Check my eligibility
What is being tested?
The Aegis Sierra Ligation System is being tested on patients with atrial fibrillation to close off the left atrial appendage using a minimally invasive approach. The goal is safety and function assessment in up to 30 participants across Canada and the US.See study design
What are the potential side effects?
Potential side effects may include complications from minimally invasive cardiac procedures such as bleeding or infection at the access site, allergic reactions (especially if sensitive to nickel), heart rhythm problems due to manipulation of the heart's structure.
LASSO-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of irregular heartbeat not related to heart valve issues.
Select...
I am 18 years old or older.
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I can take medication to prevent blood clots after a surgical procedure.
LASSO-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline to 6-months and 1-year from procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline to 6-months and 1-year from procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants free from the safety composite of device or procedure-related Major Adverse Events
Secondary outcome measures
Number of participants that achieve Procedural Success
Number of participants that achieve Technical Success
Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE)
+13 moreLASSO-AF Trial Design
1Treatment groups
Experimental Treatment
Group I: Aegis Sierra Ligation SystemExperimental Treatment1 Intervention
The Aegis Sierra Ligation System is a series of devices designed for epicardial ligation of the Left Atrial Appendage through a minimally invasive transcatheter approach.
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Who is running the clinical trial?
Aegis Medical InnovationsLead Sponsor
Applied Health Research CentreOTHER
22 Previous Clinical Trials
71,029 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
308 Patients Enrolled for Atrial Fibrillation
Sheldon Singh, MDPrincipal InvestigatorSunnybrook Health Sciences Centre, Ontario Canada
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Doctors think you have less than 2 years to live.I do not have a condition where my heart can't pump enough blood.I have not had a stroke or mini-stroke in the last 3 months.I have had heart surgery that involved opening the protective covering of the heart.Your echocardiogram or CT scan does not show a specific part of your heart called the left atrial appendage.I have been diagnosed with a type of irregular heartbeat not related to heart valve issues.You have a score of 2 or higher on the CHA2DS2-VASc assessment.You have had serious chest injury to the front of your chest in the past.You cannot undergo a transesophageal echocardiography (TEE) for health reasons.Your body part being studied doesn't look normal in the pictures taken by the doctors.You are allergic to nickel.You have certain health conditions that make it risky to access the area around your heart.I understand the study's purpose, importance, and procedures.I am 18 years old or older.I can take medication to prevent blood clots after a surgical procedure.I cannot take blood thinners or anti-clotting medications.I have a heart condition present from birth or abnormal connections in my heart or lungs.I have severe heart failure symptoms.I have right heart dysfunction or high blood pressure in my lungs.I have a significant heart valve problem or a mechanical heart valve.My condition involves a tumor in the heart.I have had radiation therapy to the chest area before.I have had pericarditis or issues related to the pericardium.I am currently on long-term steroid treatment, not just for breathing issues.I do not have severe liver, kidney, or lung disease.I have had a heart attack in the last 3 months.I have symptoms or known issues with my carotid artery or aorta.You have a blood clot in a specific part of your heart or it was seen on a special heart test within 48 hours before the procedure.My heart's pumping ability is significantly reduced.I have a valid reason to avoid blood thinner pills.I have not had chemotherapy in the last 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: Aegis Sierra Ligation System
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many geographic points are presently offering this trial?
"Mount Sinai Hospital in New york, New York; St. Paul's Hospital - Heart Rhythm Research in Vancouver, California; and Pacific Heart Institute in Santa Monica, Ontario are the primary sites of this trial with supplemental locations across 7 additional medical centres."
Answered by AI
Are there currently opportunities to participate in this investigation?
"Clinicaltrials.gov reveals that the trial, first published on August 25th, 2017 and last edited May 29th 2019 has concluded recruitment. However, there are still 476 other trials currently seeking participants."
Answered by AI
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