- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02583178
Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation (LASSO-AF)
A Single-arm, Open Label, Multi-Centre Feasibility Study of the Aegis Sierra Ligation System in Left Atrial Appendage Closure in Patients With Atrial Fibrillation
The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation System in accessing and closing off the left atrial appendage (LAA) using a minimally invasive epicardial access approach.
A minimum of 30 participants will be included in this study, which is being performed at a maximum of 8 centers in Canada and the United States. (A maximum of 15 participants at 4 US centers will be enrolled)
Participants will be considered for this treatment if their doctor(s) have determined they have documented non-valvular atrial fibrillation and are at increased risk for developing a stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Purpose:
The objective of this early feasibility study is to assess the safety and function of the Aegis Sierra Ligation System (SLS) in ligating the left atrial appendage in patients with non-valvular atrial fibrillation and at risk for stroke. The results of this trial will be used to inform a larger pivotal trial that will allow for further health technology assessment and for Medical Device License applications.
General Design:
This is a prospective, single-arm, open-label, multi-center study. This study will screen patients with atrial fibrillation at risk for stroke. A minimum of 30 patients that meet all of the study's inclusion criteria, none of the exclusion criteria and consent to study participation will be enrolled. Patient accruement will take place at up to 8 North American centers (A maximum of 15 participants at 4 US centers will be enrolled).
Each subject will undergo the following study visits: Screening, LAA ligation Procedure (Day 0) and Post-procedure, Hospital Discharge, Day 7, Day 30, Day 90, Day 180 and Day 365.
The total duration of participation for subjects is anticipated to be 5 years post ligation procedure with the primary safety outcome assessed at the 30-day follow-up and the secondary endpoints assessed at Days 30, 180 and 365. Subjects will be also be contacted for an annual telephone follow-up evaluation from years 2 through 5 to assess for patient-reported long-term Major Adverse Events (MAE) and current health status.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6E 1M7
- St. Paul's Hospital - Heart Rhythm Research
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Victoria, British Columbia, Canada, V8T1Z4
- Victoria Cardiac Arrhythmia Trials
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Ontario
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Toronto, Ontario, Canada, M4N3M5
- SunnyBrook Health Sciences Centre
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California
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Santa Monica, California, United States, 90404
- Pacific Heart Institute
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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New York
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New York, New York, United States, 10029
- Mount Sinai Hospital
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Texas
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Houston, Texas, United States, 77030
- Houston Methodist Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >=18 years
- Documented non-valvular atrial fibrillation
- Current CHA2DS2-VASc score of ≥2
- Have an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation (OAC) therapy
- Willing and able to provide written informed consent
- Willing and able to comply with study procedures and follow-up visits.
- Able to take antiplatelet therapy post ligation procedure
Exclusion Criteria:
- Cardiogenic shock or hemodynamic instability
- Myocardial infarction in the past 3 months
- Cerebral embolism, stroke, or TIA in past 3 months
- Absence of a defined left atrial appendage on echocardiogram or CT scan
- Previous cardiac surgery involving opening of the pericardium
- History of pericarditis or pericardial tumor, a history of constrictive pericarditis or features which in the opinion of the investigator are suggestive of constrictive pericarditis
- History of significant chest trauma of the anterior chest
- Estimated life expectancy < 24 months
- Chemotherapy in the past 12 months
- Prior thoracic radiation therapy
- Chronic liver disease (greater than Child-Pugh Class A), chronic renal disease/insufficiency/failure (creatinine >3.0 mg/dL and/or renal replacement therapy at the time of screening), or chronic end stage pulmonary disease (FEV1 less than 30% predicted).
- Current use of long-term treatment with steroids. Does not include intermittent use of inhaled steroids for respiratory diseases.
- Contraindication to transesophageal echocardiography (TEE).
- Absolute contraindication to anticoagulation or antiplatelet therapy
- Congenital Heart Disease or intracardiac/intrapulmonary shunts
- Symptomatic or known significant carotid disease and/ or aortic arch atheroma
- Known thrombus in the LAA/LA or thrombus visualized by TEE within 48 hours before procedure
- Left ventricular ejection fraction (LVEF) below 30%
- Pregnant, breastfeeding or planning pregnancy within next 12 months
- Inappropriate appendage morphology (aberrant anatomy) as determined by imaging and assessed by Central Screening Committee
- Current NYHA Class IV heart failure symptoms
- Right ventricular dysfunction and /or pulmonary hypertension (>=50mmHG)
- Moderate or greater valve disease (i.e., MVA <1.5cm2, AVA <1.5cm2), history of rheumatic mitral stenosis, or mechanical valve prosthesis.
- Cardiac tumour
- Known hypersensitivity to nickel
- Patients in whom pericardial access will put the patient at risk (e.g. scoliosis, pectus excavatum, massive obesity with a BMI >40) as determined by clinical site Principal Investigator or Central Screening Committee.
- Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study.
- Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study.
- Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator or Central Screening Committee (e.g., uncontrolled drug and/or alcohol addiction, extreme frailty).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aegis Sierra Ligation System
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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The SLS is a series of devices designed for epicardial ligation of the left atrial appendage through a minimally invasive transcatheter approach.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants free from the safety composite of device or procedure-related Major Adverse Events
Time Frame: Day 30 from procedure
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Major Adverse Events : (defined as)
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Day 30 from procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants that experience a safety composite event
Time Frame: Day 30, 6-months and 1-year from procedure
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Components of the safety composites: All-cause death, stroke, trans-ischemic attack (TIA), systemic embolism
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience all-cause death
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that experience all-cause death at each designated time-point
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience stroke
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that experience stroke at each designated time-point
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience a trans-ischemic attack (TIA)
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that experience TIA at each designated time-point
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience systemic embolism
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that experience systemic embolism at each designated time-point
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience severe pericarditis
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that experience severe pericarditis at each designated time-point
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience worsening heart failure
Time Frame: Day 30, 6-months and 1-year from procedure
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Worsening heart failure is defined as an increase in New York Heart Association (NYHA) Class ≥ category
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience a new occurrence of left atrial thrombus
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that experience a new occurrence of LAA thrombus at each designated time-point
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Day 30, 6-months and 1-year from procedure
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Number of participants that experience an access site wound infection requiring IV antibiotics
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that experience an access site wound infection requiring antibiotics at each designated time-point
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Day 30, 6-months and 1-year from procedure
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Number of participants that achieve Technical Success
Time Frame: Assessed at end of procedure
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Technical success is defined as proper placement and positioning of the device includes the ability to access the pericardium, locate and grasp the LAA, and secure the ligating loop
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Assessed at end of procedure
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Number of participants that achieve Procedural Success
Time Frame: Hospitalization period
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Defined as Technical Success and no Major Adverse Events
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Hospitalization period
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Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE)
Time Frame: Day 30, 6-months and 1-year from procedure
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Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE) at each time-point
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Day 30, 6-months and 1-year from procedure
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The reported average change in B-type Natriuretic Peptide (BNP)
Time Frame: Change between baseline and 6-months from procedure
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Reported in picomole/liter (pmol/L)
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Change between baseline and 6-months from procedure
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The reported average change in the rating of atrial fibrillation burden as measured the University of Toronto Atrial Fibrillation Severity Scale (AFSS v. Sept 25, 2014)
Time Frame: Change between baseline to 6-months and 1-year from procedure
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Change in AFSS score between baseline to 6-months and 1-year from procedure will be reported
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Change between baseline to 6-months and 1-year from procedure
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The reported average change in Health Related Quality of Life scoring as measured by the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT v.1.0)
Time Frame: Change between baseline to Day 30, 6-months, and 1-year from procedure
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Change in AFEQT score between baseline, Day 30, 6-months and 1-year from procedure will be reported
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Change between baseline to Day 30, 6-months, and 1-year from procedure
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The average change in patient reported pain as measured by the Numeric Rating Scale (NRS-11) pain scale.
Time Frame: Change from baseline to hospital discharge, Day 7, and Day 30 from procedure
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Change in NRS pain score between baseline, hospital discharge,Day 7, and Day 30 from procedure will be reported
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Change from baseline to hospital discharge, Day 7, and Day 30 from procedure
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheldon Singh, MD, Sunnybrook Health Sciences Centre, Ontario Canada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGS-CLIN-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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