Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT03133806
Status:
UNKNOWN
Last Update Posted:
2017-04-28
First Post:
2017-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Canadian Left Atrial Appendage Closure Study
Sponsor:
Cardia Inc.
Organization:
Study Overview
Official Title:
CLASS Canadian Left Atrial Appendage Closure Study
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLASS
Brief Summary:
The purpose of the study is to demonstrate the safety and the rate of closure of the Ultrasept Left Atrial Appendage (LAA) Closure System for the percutaneous occlusion of the left atrial appendage in patients with non-valvular atrial fibrillation.
Detailed Description:
The CLASS study is a multicenter, prospective, single arm trial designed to demonstrate the feasibility and short term efficacy of the Ultrasept Left Atrial Appendage Closure Device. Patients who present or are referred for participation in the study will be evaluated against the inclusion and exclusion criteria. Those meeting the criteria will be given the opportunity to participate. All patients will have protocol-required evaluations at each scheduled follow-up.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: