NCT03133806

Canadian Left Atrial Appendage Closure Study

CLASS Canadian Left Atrial Appendage Closure Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cardia Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Left Atrial Appendage
• Non-Valvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Ultrasept LAA Closure System	The Ultrasept Left Atrial Appendage Closure System Device is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation.

Timeline

• Start date: 2017-02-15
• Primary completion: 2018-08-01
• Completion: 2018-08-15
• First posted: 2017-04-28
• Last updated: 2017-04-28

Locations

1 site across 1 country: Canada