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Status unknownNCT02583178LASSO-AFUpdated May 30, 2019

Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation

An interventional study of Aegis Sierra Ligation System in Atrial Fibrillation, sponsored by Aegis Medical Innovations. Status unknown at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Aegis Medical Innovations · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 7 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Aegis Medical Innovations as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age >=18 years
  2. Documented non-valvular atrial fibrillation
  3. Current CHA2DS2-VASc score of ≥2
  4. Have an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation (OAC) therapy
  5. Willing and able to provide written informed consent
  6. Willing and able to comply with study procedures and follow-up visits.
  7. Able to take antiplatelet therapy post ligation procedure

Exclusion criteria

Exclusion Criteria:

  1. Cardiogenic shock or hemodynamic instability
  2. Myocardial infarction in the past 3 months
  3. Cerebral embolism, stroke, or TIA in past 3 months
  4. Absence of a defined left atrial appendage on echocardiogram or CT scan
  5. Previous cardiac surgery involving opening of the pericardium
  6. 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
  7. History of significant chest trauma of the anterior chest
  8. Estimated life expectancy \< 24 months
  9. Chemotherapy in the past 12 months
  10. Prior thoracic radiation therapy
  11. 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).
  12. Current use of long-term treatment with steroids. Does not include intermittent use of inhaled steroids for respiratory diseases.
  13. Contraindication to transesophageal echocardiography (TEE).
  14. Absolute contraindication to anticoagulation or antiplatelet therapy
  15. Congenital Heart Disease or intracardiac/intrapulmonary shunts
  16. Symptomatic or known significant carotid disease and/ or aortic arch atheroma
  17. Known thrombus in the LAA/LA or thrombus visualized by TEE within 48 hours before procedure
  18. Left ventricular ejection fraction (LVEF) below 30%
  19. Pregnant, breastfeeding or planning pregnancy within next 12 months
  20. Inappropriate appendage morphology (aberrant anatomy) as determined by imaging and assessed by Central Screening Committee
  21. Current NYHA Class IV heart failure symptoms
  22. Right ventricular dysfunction and /or pulmonary hypertension (>=50mmHG)
  23. Moderate or greater valve disease (i.e., MVA \<1.5cm2, AVA \<1.5cm2), history of rheumatic mitral stenosis, or mechanical valve prosthesis.
  24. Cardiac tumour
  25. Known hypersensitivity to nickel
  26. 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.
  27. Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study.
  28. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study.
  29. 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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.

    Device: Aegis Sierra Ligation System

Interventions

  • DeviceAegis Sierra Ligation System

    The SLS is a series of devices designed for epicardial ligation of the left atrial appendage through a minimally invasive transcatheter approach.

    Also known as: Sierra Ligation System, SLS

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 30 from procedure

Secondary outcomes

  1. Number of participants that experience a safety composite event

    Components of the safety composites: All-cause death, stroke, trans-ischemic attack (TIA), systemic embolism

    Time frame: Day 30, 6-months and 1-year from procedure

  2. Number of participants that experience all-cause death

    Number of participants that experience all-cause death at each designated time-point

    Time frame: Day 30, 6-months and 1-year from procedure

  3. Number of participants that experience stroke

    Number of participants that experience stroke at each designated time-point

    Time frame: Day 30, 6-months and 1-year from procedure

  4. Number of participants that experience a trans-ischemic attack (TIA)

    Number of participants that experience TIA at each designated time-point

    Time frame: Day 30, 6-months and 1-year from procedure

  5. Number of participants that experience systemic embolism

    Number of participants that experience systemic embolism at each designated time-point

    Time frame: Day 30, 6-months and 1-year from procedure

  6. Number of participants that experience severe pericarditis

    Number of participants that experience severe pericarditis at each designated time-point

    Time frame: Day 30, 6-months and 1-year from procedure

  7. Number of participants that experience worsening heart failure

    Worsening heart failure is defined as an increase in New York Heart Association (NYHA) Class ≥ category

    Time frame: Day 30, 6-months and 1-year from procedure

  8. 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

    Time frame: Day 30, 6-months and 1-year from procedure

  9. 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

    Time frame: Day 30, 6-months and 1-year from procedure

  10. 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

    Time frame: Assessed at end of procedure

  11. Number of participants that achieve Procedural Success

    Defined as Technical Success and no Major Adverse Events

    Time frame: Hospitalization period

  12. 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

    Time frame: Day 30, 6-months and 1-year from procedure

  13. The reported average change in B-type Natriuretic Peptide (BNP)

    Reported in picomole/liter (pmol/L)

    Time frame: Change between baseline and 6-months from procedure

  14. 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

    Time frame: Change between baseline to 6-months and 1-year from procedure

  15. 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

    Time frame: Change between baseline to Day 30, 6-months, and 1-year from procedure

  16. 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

    Time frame: Change from baseline to hospital discharge, Day 7, and Day 30 from procedure

07

Study locations

7 sites
  • Pacific Heart Institute
    Santa Monica, California 90404, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Mount Sinai Hospital
    New York, New York 10029, United States
  • Houston Methodist Research Institute
    Houston, Texas 77030, United States
  • St. Paul's Hospital - Heart Rhythm Research
    Vancouver, British Columbia V6E 1M7, Canada
  • Victoria Cardiac Arrhythmia Trials
    Victoria, British Columbia V8T1Z4, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N3M5, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2017 (actual). Primary completion is estimated for Aug 2020, 36 months after the start.

Of 242 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 36 months is above that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2015
First posted
Oct 22, 2015
StartActual
Aug 25, 2017
Primary completionEst.
Aug 2020
CompletionEst.
Aug 2024
Last update
May 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02583178
Lead sponsor
Aegis Medical Innovations
Collaborators
Applied Health Research Centre
Responsible party
Sponsor
First posted
Oct 22, 2015
Start date
Aug 25, 2017
Primary completion
Aug 2020 (estimated)
Completion
Aug 2024 (estimated)
Last update
May 30, 2019

Study contacts

Sheldon Singh, MD
principal investigator · Sunnybrook Health Sciences Centre, Ontario Canada

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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