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Zenith LAA Occlusion System

NCT05951101 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-16

No results posted yet for this study

Summary

Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.

Indication - LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 18 mm and 26 mm

Conditions

Interventions

DEVICE

Zenith LAA Occlusion System

LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm

Sponsors & Collaborators

  • AuriGen Medical Ltd

    lead INDUSTRY

Principal Investigators

  • Felix Mahfoud · Internal Medicine and Cardiology, Saarland University Hospital

  • Christian Ukena · Saarland University Hospital

  • Sandeep Panikker · University Hospitals Coventry & Warwickshire NHS Trust

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2025-01-31
Completion
2025-12-31

Countries

  • Australia
  • New Zealand

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 NCT05951101 on ClinicalTrials.gov