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

ID#: NCT02583178

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: August 25, 2017

End Date: August 01, 2023

Contact Information:
Trevor McCaw, MBA
Zoe Nguyen
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.

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).