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

NCT02583178 | Unknown DMC FDA Device

• 1 other identifier: AGS-CLIN-003
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 7

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of participants free from the safety composite of device or procedure-related Major Adverse Events

  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

  Day 30 from procedure

Secondary Outcomes (16)

• Number of participants that experience a safety composite event

  Day 30, 6-months and 1-year from procedure

• Number of participants that experience all-cause death

  Day 30, 6-months and 1-year from procedure

• Number of participants that experience stroke

  Day 30, 6-months and 1-year from procedure

• Number of participants that experience a trans-ischemic attack (TIA)

  Day 30, 6-months and 1-year from procedure

• Number of participants that experience systemic embolism

  Day 30, 6-months and 1-year from procedure

Study Arms (1)

Aegis Sierra Ligation System

EXPERIMENTAL

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.

Device: Aegis Sierra Ligation System

Interventions

Aegis Sierra Ligation System DEVICE

The SLS is a series of devices designed for epicardial ligation of the left atrial appendage through a minimally invasive transcatheter approach.

Also known as: Sierra Ligation System, SLS

Aegis Sierra Ligation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Aegis Medical Innovations: lead
• Applied Health Research Centre: collaborator

Study Sites (7)

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

St. Paul's Hospital - Heart Rhythm Research

Vancouver, British Columbia, V6E 1M7, Canada

Location

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, V8T1Z4, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheldon Singh, MD

  Sunnybrook Health Sciences Centre, Ontario Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: August 25, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2024
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

CA (3); US (4)