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Trial record 1 of 1 for:    NCT02583178
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Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation (LASSO-AF)

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ClinicalTrials.gov Identifier: NCT02583178
Recruitment Status : Active, not recruiting
First Posted : October 22, 2015
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Aegis Medical Innovations

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE October 22, 2015
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE August 25, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
Freedom from the 30-day safety composite of the following device or procedure-related Major Adverse Events [ Time Frame: 30 days (+/- 10 days) 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
  • All-cause death, stroke, TIA, or systemic embolism [ Time Frame: Day 30, 6-months and 1-year from procedure ]
  • Each component of the safety composite [ 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
  • Each of the following adverse events: Severe pericarditis, worsening heart failure [increase in New York Heart Association (NYHA) Class >1 category], new occurrence of left atrial thrombus,wound infection from access site requiring IV antibiotics [ Time Frame: Day 30, 6-months and 1-year from procedure ]
  • Technical Success as defined by proper placement and positioning of the device and a reduction to ≤ 3mm residual flow distal to the closure site as measured by trans-esophageal echocardiogram (TEE) at end of study procedure [ Time Frame: Assessed at end of procedure ]
    Proper placement and positioning of the device includes the ability to access the pericardium, locate and grasp the LAA, and secure the ligating loop
  • Procedural Success as defined by Technical Success and no Major Adverse Events [ Time Frame: Hospitalization period ]
  • Residual flow ≤ 3mm distal to the closure site as measured by TEE [ Time Frame: Day 30, 6-months and 1-year from procedure ]
  • Change in B-type Natriuretic Peptide (BNP) and Atrial Natriuretic Peptide (ANP) [ Time Frame: Between baseline and 6-months from procedure ]
  • 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: Between baseline, 6-months and 1-year from procedure ]
  • 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: Between baseline, Day 30, 6-months, and 1-year from procedure ]
  • Change from baseline as measured by the Numeric Rating Scale (NRS-11) pain scale. [ Time Frame: From baseline to hospital discharge, Day 7, and Day 30 from procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation
Official Title  ICMJE 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
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Aegis Sierra Ligation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2015)
25
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02583178
Other Study ID Numbers  ICMJE AGS-CLIN-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Aegis Medical Innovations
Study Sponsor  ICMJE Aegis Medical Innovations
Collaborators  ICMJE Applied Health Research Centre
Investigators  ICMJE
Principal Investigator: Sheldon Singh, MD Sunnybrook Health Sciences Centre, Ontario Canada
PRS Account Aegis Medical Innovations
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP