What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include mechanical procedures like left atrial appendage (LAA) closure devices and catheter ablation, as well as pharmacological treatments. LAA closure devices, such as the Aegis Sierra Ligation System, can lead to complications like device-related thrombus, pericardial effusion, and procedural complications. Catheter ablation may result in risks such as bleeding, infection, pulmonary vein stenosis, and esophageal injury. Pharmacological treatments, including antiarrhythmic drugs like amiodarone and dronedarone, can cause side effects such as liver toxicity, lung toxicity, thyroid dysfunction, and increased risk of cardiovascular events.

What prior FDA approvals exist?

The FDA has approved several devices for the treatment of Atrial Fibrillation (AF) that focus on mechanical closure of the left atrial appendage (LAA) to prevent stroke. Notable among these are the WATCHMAN device and the LARIAT device. These devices provide an alternative to long-term anticoagulation therapy by mechanically isolating the LAA, thereby reducing the risk of thromboembolic events in patients with non-valvular AF.

What other types of research exist?

Promising alternatives to the Aegis Sierra Ligation System for LAA closure in AF patients include the WATCHMAN device, which has been shown to be non-inferior to warfarin for stroke prevention and has a new fourth-generation model designed for easier delivery and improved safety. Additionally, the use of direct oral anticoagulants (DOACs) like rivaroxaban in combination with aspirin has shown efficacy in reducing stroke risk in AF patients, although with an increased risk of bleeding. These options provide both mechanical and pharmacological alternatives for stroke prevention in AF patients.

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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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 17Eligibility criteria met

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].