Atrial FibrillationLASSO-AFNCT02583178
Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation
A study testing Aegis Sierra Ligation System in people with Atrial Fibrillation, run by Aegis Medical Innovations at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Aegis Sierra Ligation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 25 Aug 2017to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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).
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Houston Methodist Research Institute
Houston, Texas, 77030
Mount Sinai Hospital
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
Pacific Heart Institute
Santa Monica, California, 90404
Canada3 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
St. Paul's Hospital - Heart Rhythm Research
Vancouver, British Columbia, V6E 1M7
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8T1Z4
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Aegis Sierra Ligation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aegis Sierra Ligation SystemDevice
Also called Sierra Ligation System, SLS
The SLS is a series of devices designed for epicardial ligation of the left atrial appendage through a minimally invasive transcatheter approach.
| Study group | Role | What they receive |
|---|---|---|
| Aegis Sierra Ligation System | Experimental | 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. Receives: Device: Aegis Sierra Ligation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants free from the safety composite of device or procedure-related Major Adverse Events
Major Adverse Events : (defined as)
- All-cause death
- Stroke
- Systemic embolism
- Major or life-threatening bleeding (VARC-II definition),
- Injury to coronary arteries requiring intervention,
- Myocardial infarction (VARC-II definition),
- Unplanned operation or interventional procedure for device or procedure related complications (including drainage of pericardial effusion),
- Complications related to epicardial access
Measured: Day 30 from procedure
Secondary outcomes (16)
Number of participants that experience a safety composite event
Components of the safety composites: All-cause death, stroke, trans-ischemic attack (TIA), systemic embolism
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience all-cause death
Number of participants that experience all-cause death at each designated time-point
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience stroke
Number of participants that experience stroke at each designated time-point
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience a trans-ischemic attack (TIA)
Number of participants that experience TIA at each designated time-point
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience systemic embolism
Number of participants that experience systemic embolism at each designated time-point
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience severe pericarditis
Number of participants that experience severe pericarditis at each designated time-point
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience worsening heart failure
Worsening heart failure is defined as an increase in New York Heart Association (NYHA) Class ≥ category
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience a new occurrence of left atrial thrombus
Number of participants that experience a new occurrence of LAA thrombus at each designated time-point
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that experience an access site wound infection requiring IV antibiotics
Number of participants that experience an access site wound infection requiring antibiotics at each designated time-point
Measured: Day 30, 6-months and 1-year from procedure
Number of participants that achieve Technical Success
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
Measured: Assessed at end of procedure
Number of participants that achieve Procedural Success
Defined as Technical Success and no Major Adverse Events
Measured: Hospitalization period
Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE)
Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE) at each time-point
Measured: Day 30, 6-months and 1-year from procedure
The reported average change in B-type Natriuretic Peptide (BNP)
Reported in picomole/liter (pmol/L)
Measured: Change between baseline and 6-months from procedure
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)
Change in AFSS score between baseline to 6-months and 1-year from procedure will be reported
Measured: Change between baseline to 6-months and 1-year from procedure
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)
Change in AFEQT score between baseline, Day 30, 6-months and 1-year from procedure will be reported
Measured: Change between baseline to Day 30, 6-months, and 1-year from procedure
The average change in patient reported pain as measured by the Numeric Rating Scale (NRS-11) pain scale.
Change in NRS pain score between baseline, hospital discharge,Day 7, and Day 30 from procedure will be reported
Measured: Change from baseline to hospital discharge, Day 7, and Day 30 from procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start25 Aug 2017
- Primary completionAug 2020 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aegis Medical Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Applied Health Research Centre
- Responsible party
- Sponsor
- Investigators
- Sheldon Singh, MD, Principal investigator, Sunnybrook Health Sciences Centre, Ontario Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583178
- Sponsor's protocol ID
- AGS-CLIN-003
- Acronym
- LASSO-AF
- Status last verified
- May 2019
- First submitted
- 20 Oct 2015
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02583178
- Acronym / sponsor ID
- LASSO-AF / AGS-CLIN-003
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Aegis Medical InnovationsIndustry (pharma, biotech, devices)
- Collaborators
- Applied Health Research Centre
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aegis Sierra Ligation System | Experimental | Device: Aegis Sierra Ligation SystemThe Aegis Sierra Ligation System is a series of devices designed for epicardial ligation of the Left Atrial Appendage through a minimally invasive transcatheter approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aegis Sierra Ligation SystemAlso: Sierra Ligation System, SLSThe SLS is a series of devices designed for epicardial ligation of the left atrial appendage through a minimally invasive transcatheter approach. | Device | Aegis Sierra Ligation System |
Primary outcome
Number of participants free from the safety composite of device or procedure-related Major Adverse Events
Time frame: Day 30 from procedure
Major Adverse Events : (defined as) * All-cause death * Stroke * Systemic embolism * Major or life-threatening bleeding (VARC-II definition), * Injury to coronary arteries requiring intervention, * Myocardial infarction (VARC-II definition), * Unplanned operation or interventional procedure for device or procedure related complications (including drainage of pericardial effusion), * Complications related to epicardial access
16 secondary outcomes
Number of participants that experience a safety composite event
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience all-cause death
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience stroke
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience a trans-ischemic attack (TIA)
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience systemic embolism
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience severe pericarditis
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience worsening heart failure
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience a new occurrence of left atrial thrombus
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that experience an access site wound infection requiring IV antibiotics
Time frame: Day 30, 6-months and 1-year from procedure
Number of participants that achieve Technical Success
Time frame: Assessed at end of procedure
Number of participants that achieve Procedural Success
Time frame: Hospitalization period
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
The reported average change in B-type Natriuretic Peptide (BNP)
Time frame: Change between baseline and 6-months from procedure
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Atrial Fibrillation (AF)
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Singh, MD principal investigator
Sunnybrook Health Sciences Centre, Ontario Canada
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aegis Sierra Ligation System in people with Atrial Fibrillation, run by Aegis Medical Innovations at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants free from the safety composite of device or procedure-related Major Adverse Events (time frame: Day 30 from procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019; AzTrials last refreshed its copy on 3 Nov 2026.