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Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk

NCT04829929 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-03

No results posted yet for this study

Summary

The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk.

Conditions

  • Non-Valvular Atrial Fibrillation

Interventions

DEVICE

Omega™LAA Occluder implantation

Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Cardiovascular Research Institute Dublin

    collaborator OTHER

  • Eclipse Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Horst Sievert, profesor · Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2025-02-19
Completion
2027-01-07

Countries

  • Denmark
  • Germany
  • Ireland
  • Italy
  • Spain
  • United Kingdom

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 NCT04829929 on ClinicalTrials.gov