Clinical trial NCT02583178: Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Aegis Medical Innovations
Sponsor class: INDUSTRY
Collaborators: name: Applied Health Research Centre
First posted: 2015-10-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Number of participants free from the safety composite of device or procedure-related Major Adverse Events
timeFrame: Day 30 from procedure
Secondary outcomes:
measure: Number of participants that experience a safety composite event
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience all-cause death
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience stroke
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience a trans-ischemic attack (TIA)
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience systemic embolism
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience severe pericarditis
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience worsening heart failure
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience a new occurrence of left atrial thrombus
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that experience an access site wound infection requiring IV antibiotics
timeFrame: Day 30, 6-months and 1-year from procedure
measure: Number of participants that achieve Technical Success
timeFrame: Assessed at end of procedure
measure: Number of participants that achieve Procedural Success
timeFrame: Hospitalization period
measure: Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE)
timeFrame: Day 30, 6-months and 1-year from procedure
measure: The reported average change in B-type Natriuretic Peptide (BNP)
timeFrame: Change between baseline and 6-months from procedure
measure: 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)
timeFrame: Change between baseline to 6-months and 1-year from procedure
measure: 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)
timeFrame: Change between baseline to Day 30, 6-months, and 1-year from procedure
measure: The average change in patient reported pain as measured by the Numeric Rating Scale (NRS-11) pain scale.
timeFrame: Change from baseline to hospital discharge, Day 7, and Day 30 from procedure
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Vancouver
country: Canada
facility: St. Paul's Hospital - Heart Rhythm Research
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre, Ontario Canada
name: Sheldon Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: