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

NCT02583178 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-05-30

No results posted yet for this study

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

Interventions

DEVICE

Aegis Sierra Ligation System

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

Sponsors & Collaborators

  • Applied Health Research Centre

    collaborator OTHER

  • Aegis Medical Innovations

    lead INDUSTRY

Principal Investigators

  • Sheldon Singh, MD · Sunnybrook Health Sciences Centre, Ontario Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-25
Primary Completion
2020-08-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583178 on ClinicalTrials.gov