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Trial record 1 of 13 for:    Aegis Medical
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Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation (LASSO-AF)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Aegis Medical Innovations
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Aegis Medical Innovations
ClinicalTrials.gov Identifier:
NCT02583178
First received: October 20, 2015
Last updated: June 26, 2017
Last verified: June 2017
  Purpose

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 5 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.


Condition Intervention
Atrial Fibrillation Device: Aegis Sierra Ligation System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Aegis Medical Innovations:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Number of participants that experience a safety composite event [ Time Frame: Day 30, 6-months and 1-year from procedure ]
    Components of the safety composites: All-cause death, stroke, trans-ischemic attack (TIA), systemic embolism

  • Number of participants that experience all-cause death [ Time Frame: Day 30, 6-months and 1-year from procedure ]
    Number of participants that experience all-cause death at each designated time-point

  • Number of participants that experience stroke [ Time Frame: Day 30, 6-months and 1-year from procedure ]
    Number of participants that experience stroke at each designated time-point

  • 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 TIA at each designated time-point

  • Number of participants that experience systemic embolism [ Time Frame: Day 30, 6-months and 1-year from procedure ]
    Number of participants that experience systemic embolism at each designated time-point

  • Number of participants that experience severe pericarditis [ Time Frame: Day 30, 6-months and 1-year from procedure ]
    Number of participants that experience severe pericarditis at each designated time-point

  • Number of participants that experience worsening heart failure [ Time Frame: Day 30, 6-months and 1-year from procedure ]
    Worsening heart failure is defined as an increase in New York Heart Association (NYHA) Class ≥ category

  • 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 a new occurrence of LAA thrombus at each designated time-point

  • 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 experience an access site wound infection requiring antibiotics at each designated time-point

  • Number of participants that achieve Technical Success [ Time Frame: Assessed at end of procedure ]
    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

  • Number of participants that achieve Procedural Success [ Time Frame: Hospitalization period ]
    Defined as Technical Success and no Major Adverse Events

  • 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 ]
    Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE) at each time-point

  • The reported average change in B-type Natriuretic Peptide (BNP) [ Time Frame: Change between baseline and 6-months from procedure ]
    Reported in picomole/liter (pmol/L)

  • 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 ]
    Change in AFSS score between baseline to 6-months and 1-year from procedure will be reported

  • 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 ]
    Change in AFEQT score between baseline, Day 30, 6-months and 1-year from procedure will be reported

  • 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 ]
    Change in NRS pain score between baseline, hospital discharge,Day 7, and Day 30 from procedure will be reported


Estimated Enrollment: 30
Actual Study Start Date: March 31, 2017
Estimated Study Completion Date: February 2023
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
The SLS is a series of devices designed for epicardial ligation of the left atrial appendage through a minimally invasive transcatheter approach.
Other Names:
  • Sierra Ligation System
  • SLS

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 5 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02583178

Contacts
Contact: Trevor McCaw, MBA 1-650-440-6271 trevor@aegismedical.net
Contact: Ian McDougall 1-604-762-8377 ian@aegismedical.net

Locations
United States, California
Pacific Heart Institute Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Crystal Ducharme    310-829-7678 ext 70    Crystal.Ducharme@providence.org   
Principal Investigator: Shephal Doshi, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Katherine E Tilkes    507-284-5876    tilkes.katherine@mayo.edu   
Principal Investigator: Suraj Kapa, MD         
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Betsy Ellsworth, MSN, ANP    212-824-8902    betsy.ellsworth@mountsinai.org   
Principal Investigator: Vivek Reddy, MD         
United States, Texas
Houston Methodist Research Institute Not yet recruiting
Houston, Texas, United States, 77030
Contact: Raquel Bunge, BSN    713-441-3912    RRBunge2@houstonmethodist.org   
Principal Investigator: Miguel Valderrabano, MD         
Canada, British Columbia
St. Paul's Hospital - Heart Rhythm Research Recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Contact: Marion Thomas, PhD    604-682-2344 ext 66861    MThomas@providencehealth.bc.ca   
Principal Investigator: Marc Deyell, MD         
Victoria Cardiac Arrhythmia Trials Recruiting
Victoria, British Columbia, Canada, V8T1Z4
Contact: Deborah Parfett    250-595-0400    dparfett@catrials.org   
Principal Investigator: Chris Lane, MD         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Fahema Ahmadzai    416-480-6100 ext 7700    fahema.ahmadzai@sunnybrook.ca   
Principal Investigator: Sheldon Singh, MD         
Sponsors and Collaborators
Aegis Medical Innovations
Applied Health Research Centre
Investigators
Principal Investigator: Sheldon Singh, MD Sunnybrook Health Sciences Centre, Ontario Canada
  More Information

Responsible Party: Aegis Medical Innovations
ClinicalTrials.gov Identifier: NCT02583178     History of Changes
Other Study ID Numbers: AGS-CLIN-003
Study First Received: October 20, 2015
Last Updated: June 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2017