NCT04829929

Brief 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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
6 countries

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2020Jan 2027

Study Start

First participant enrolled

November 17, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2027

Expected
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

March 24, 2021

Last Update Submit

December 2, 2025

Conditions

Non-Valvular Atrial Fibrillation

Keywords

non-valvular atrial fibrillationleft atrial appendageoccluderLAA occluderhigh bleeding risk

Outcome Measures

Primary Outcomes (2)

  • LAA (Left Atrial Appendage) closure

    The LAA closure is defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm and assessed by Transthoracic or Transoesophageal Echo or cardiac computed tomography, with colour flow Doppler.

    According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place after the procedure - depending on local treatment standards).

  • Device related complications

    Serious adverse events (SAE)

    According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around after the procedure - depending on local treatment standards).

Secondary Outcomes (8)

  • Procedure-related complications

    Up to 7 days post-procedure

  • Device-related complications

    24 months

  • Major bleeding

    24 months

  • Ischemic stroke

    24 months

  • Systemic embolism

    24 months

  • +3 more secondary outcomes

Study Arms (1)

One arm

EXPERIMENTAL

Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk

Device: Omega™LAA Occluder implantation

Interventions

Omega™LAA Occluder implantationDEVICE

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

One arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
  • At increased risk of stroke or systemic embolism defined as a CHA2DS2-VASc score \> or = 2
  • To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
  • Able and willing to comply with the required medication regimen post-device implant
  • Able to understand and willing to provide written informed consent to participate in the study

You may not qualify if:

  • Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation
  • Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oral anticoagulant (NOAC) use
  • Has any contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transoesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
  • Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
  • Myocardial infarction (MI) within 90 days prior to implant
  • New York Heart Association Class IV Congestive Heart Failure
  • Left ventricular ejection Fraction (LVEF) \< or = 30%
  • Left atrial appendage is obliterated or surgically ligated
  • Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
  • Active endocarditis or other infection producing bacteraemia
  • Subject has a known malignancy or other illness where life expectancy is less than 2 years
  • Impaired renal function with eGFR \<30 ml/min/1.73 m2
  • Intracardiac thrombus - including LAA - visualized by echocardiographic imaging
  • Significant mitral valve stenosis (i.e. mitral valve area \<1.5 cm2)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Rigshospitalet, Kardiologisk klinik B 2011

Copenhagen, Blegdamsvej 9, 2100, Denmark

Location

Aarhus University Hospital

Aarhus, DK-8200, Denmark

Location

CardioVasculäres Centrum, Seckbacher Landstrasse 65

Frankfurt, Frankfurt, 60389, Germany

Location

Charité - University Medicine Berlin - Campus Benjamin Franklin

Berlin, Hindenburgdamm 30, 12203 Berlin, Germany

Location

Herzzentrum Leipzig

Leipzig, Strümpellstraße 39, 04289, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Wilhelm-Epstein-Str. 4, 60431, Germany

Location

Mater Private Network

Dublin, D07 WKW8, Ireland

Location

Università Campus Biomedico Roma

Rome, Via Álvaro Del Portillo, 200, 00128, Italy

Location

Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario

Valladolid, Avda. Ramón Y Cajal 3, 47005, Spain

Location

Hospital Clinico San Carlos

Madrid, Calle Del Prof Martín Lagos, S/N, 28040, Spain

Location

Complejo Hospitalario de Salamanca

Salamanca, Junta de Castilla Y LeónPaseo de San Vicente, 58-182, 37007, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, Sant Antoni Maria Clare, 08025, Spain

Location

University Hospitals Sussex NHS Foundation Trust Clinical Research Facility

Brighton, East Sussex, BN2 1ES, United Kingdom

Location

Related Publications (1)

  • De Backer O, Hafiz H, Fabre A, Lertsapcharoen P, Srimahachota S, Foley D, Sondergaard L. State-of-the-art preclinical testing of the OMEGATM left atrial appendage occluder. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):E1011-E1018. doi: 10.1002/ccd.29331. Epub 2020 Oct 9.

    PMID: 33034944BACKGROUND

Study Officials

  • Horst Sievert, profesor

    Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 2, 2021

Study Start

November 17, 2020

Primary Completion

February 19, 2025

Study Completion (Estimated)

January 7, 2027

Last Updated

December 3, 2025

Record last verified: 2025-12

Locations

IE(1)IT(1)DE(4)DK(2)GB(1)ES(4)