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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
Must not have
Cardiogenic shock or hemodynamic instability
Previous cardiac surgery involving opening of the pericardium
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline to 6-months and 1-year from procedure
Awards & highlights

Summary

This trial is testing a new device called the Aegis Sierra Ligation System, which is used to close off a small part of the heart. It targets patients with a specific type of irregular heartbeat who are at high risk for stroke. The device works by making a small incision and sealing off the area to prevent blood clots.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of irregular heartbeat not related to heart valve issues.
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I am 18 years old or older.
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I can take medication to prevent blood clots after a surgical procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a condition where my heart can't pump enough blood.
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I have had heart surgery that involved opening the protective covering of the heart.
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I have had radiation therapy to the chest area before.
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I do not have severe liver, kidney, or lung disease.
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I understand the study's purpose, importance, and procedures.
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I cannot take blood thinners or anti-clotting medications.
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I have a heart condition present from birth or abnormal connections in my heart or lungs.
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I have severe heart failure symptoms.
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I have right heart dysfunction or high blood pressure in my lungs.
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I have a significant heart valve problem or a mechanical heart valve.
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My condition involves a tumor in the heart.
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I have symptoms or known issues with my carotid artery or aorta.
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My heart's pumping ability is significantly reduced.
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I have not had chemotherapy in the last 12 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline to 6-months and 1-year from procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline to 6-months and 1-year from procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants free from the safety composite of device or procedure-related Major Adverse Events
Secondary study objectives
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 more

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Atrial Fibrillation (AF) include pharmacological approaches like rate control medications (beta-blockers, calcium channel blockers) and rhythm control medications (antiarrhythmics), as well as anticoagulants to prevent stroke. Non-pharmacological treatments involve electrical cardioversion and catheter ablation. The Aegis Sierra Ligation System, a mechanical ligation device, specifically targets the left atrial appendage (LAA) to prevent stroke by closing off this area where blood clots often form. This is significant for AF patients as it provides a minimally invasive method to reduce stroke risk, potentially eliminating the need for long-term anticoagulation therapy.
[Treatment of Patients With Atrial Fibrillation: the Search for Optimal Solutions].

Find a Location

Who is running the clinical trial?

Aegis Medical InnovationsLead Sponsor
Applied Health Research CentreOTHER
22 Previous Clinical Trials
70,889 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

Aegis Sierra Ligation System (Ligation Device) Clinical Trial Eligibility Overview. Trial Name: NCT02583178 — N/A
Atrial Fibrillation Research Study Groups: Aegis Sierra Ligation System
Aegis Sierra Ligation System (Ligation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02583178 — N/A
Atrial Fibrillation Clinical Trial 2023: Aegis Sierra Ligation System Highlights & Side Effects. Trial Name: NCT02583178 — N/A
~1 spots leftby Oct 2025