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

Status unconfirmed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID: NCT02583178
Run by: Aegis Medical Innovations
People needed: 7
Starts: 2017-08-25
Expected to finish: 2024-08-01
Last updated by the study team: 2019-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Cardiogenic shock or hemodynamic instability
Myocardial infarction in the past 3 months
Cerebral embolism, stroke, or TIA in past 3 months
Absence of a defined left atrial appendage on echocardiogram or CT scan
Previous cardiac surgery involving opening of the pericardium
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
History of significant chest trauma of the anterior chest
Estimated life expectancy < 24 months
Chemotherapy in the past 12 months
Prior thoracic radiation therapy
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).
Current use of long-term treatment with steroids. Does not include intermittent use of inhaled steroids for respiratory diseases.
Contraindication to transesophageal echocardiography (TEE).
Absolute contraindication to anticoagulation or antiplatelet therapy
Congenital Heart Disease or intracardiac/intrapulmonary shunts
Symptomatic or known significant carotid disease and/ or aortic arch atheroma
Known thrombus in the LAA/LA or thrombus visualized by TEE within 48 hours before procedure
Left ventricular ejection fraction (LVEF) below 30%
Pregnant, breastfeeding or planning pregnancy within next 12 months
Inappropriate appendage morphology (aberrant anatomy) as determined by imaging and assessed by Central Screening Committee
Current NYHA Class IV heart failure symptoms
Right ventricular dysfunction and /or pulmonary hypertension (>=50mmHG)
Moderate or greater valve disease (i.e., MVA <1.5cm2, AVA <1.5cm2), history of rheumatic mitral stenosis, or mechanical valve prosthesis.
Cardiac tumour
Known hypersensitivity to nickel

Where it is running

Pacific Heart Institute — Santa Monica, California, United States
Mayo Clinic — Rochester, Minnesota, United States
Mount Sinai Hospital — New York, New York, United States
Houston Methodist Research Institute — Houston, Texas, United States
St. Paul's Hospital - Heart Rhythm Research — Vancouver, British Columbia, Canada
Victoria Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada
Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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