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Canadian Left Atrial Appendage Closure Study

NCT03133806 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-28

No results posted yet for this study

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.

Conditions

  • Left Atrial Appendage
  • Non-Valvular Atrial Fibrillation

Interventions

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.

Sponsors & Collaborators

  • Cardia Inc.

    lead INDUSTRY

Principal Investigators

  • Reda Ibrahim, MD · Montreal Heart Institute

  • Jean-Bernard Masson, MD FRCPC · Centre hospitalier de l'Université de Montréal (CHUM)

  • Josep Rodés-Cabau, MD · Quebec Heart & Lung Institute Laval University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2018-08-31
Completion
2018-08-15

Countries

  • Canada

Study Locations

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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 NCT03133806 on ClinicalTrials.gov