Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-000979
NCT ID: NCT02583178
Sponsor Protocol Number: AGS-CLIN-003
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
- Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study.
- Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study.
- 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).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Suraj Kapa, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available