Evaluation od 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 (Omega)

Prospective, Single-arm Study to Assess the Safety and Performance of the Omega™ Left Atrial Appendage (LAA) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Valvular Atrial Fibrillation
• Intervention / Treatment: Device: Omega™LAA Occluder implantation

Detailed Description

Omega™ LAA (Left Atrial Appendage) Occluder used in combination with the indicated Omega™ Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion. LLA (Left Atrial Appendage) occlusion appears to be a feasible option for stroke reduction in AF patients at high risk for stroke, who are contraindicated for anticoagulation or who suffered a stroke despite OC. This study will evaluate safety and performance, using a study design which is based on inputs from pre-clinical testing, the risk analysis and data available from other LAA (Left Atrial Appendage) devices.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aidan Mulloy; Phone Number: +353 86 2643 765; Email: aidan@eclipse-med.com

Study Locations

• Denmark
  • Blegdamsvej 9
    • København, Blegdamsvej 9, Denmark, 2100
      • Recruiting
      • Rigshospitalet, Kardiologisk klinik B 2011
      • Contact: Ole de Backer, MD, PhD; Email: ole.de.backer@regionh.dk
      • Contact: Kirsten Thrysøe; Phone Number: 0045 3545 8262; Email: kirsten.Thrysoee@regionh.dk
      • Principal Investigator: Ole de Backer, MD, PhD
• Germany
  • Frankfurt, Germany, 60389
    • Recruiting
    • CardioVasculäres Centrum, Seckbacher Landstrasse 65
    • Contact: Horst Sievert, Profesor; Phone Number: 0049 69-4603-1344; Email: horstsievertmd@aol.com
    • Contact: Sabine de Bruijn; Phone Number: 0049 69 9794 7653; Email: s.debruijn@cvcfrankfurt.de
    • Sub-Investigator: Natalia Galeru
    • Principal Investigator: Horst Sievert, Profesor
    • Sub-Investigator: Judith Steffan
    • Sub-Investigator: Anja Vogel
    • Sub-Investigator: Kolja Sievert
  • Hindenburgdamm 30
    • Berlin, Hindenburgdamm 30, Germany, 12203 Berlin
      • Recruiting
      • Charité - University Medicine Berlin - Campus Benjamin Franklin
      • Contact: Carsten Skurk, Prof.; Phone Number: 0049450513725
  • Strümpellstraße 39
    • Leipzig, Strümpellstraße 39, Germany, 04289
      • Recruiting
      • Herzzentrum Leipzig
      • Contact: Marcus Sandri, PD Dr.; Phone Number: 0049 341 865 1428; Email: marcus.sandri@medizin.uni-leipzig.de
      • Contact: Anne-Kathrin Funkat; Email: Anne-Kathrin.Funkat@medizin.uni-leipzig.de
      • Principal Investigator: Marcus Sandri, MD Dr.
  • Wilhelm-Epstein-Str. 4
    • Frankfurt, Wilhelm-Epstein-Str. 4, Germany, 60431
      • Recruiting
      • Cardioangiologisches Centrum Bethanien
      • Contact: Boris Schmidt; Email: b.schmidt@ccb.de
      • Contact: Ines Timmermanns; Phone Number: 0049 069 945028-14; Email: i.timmermanns@ccb.de
      • Principal Investigator: Boris Schmidt, PD, Dr
      • Sub-Investigator: Julian Chun, Prof
      • Sub-Investigator: Stefano Bordignon, Dr
• Italy
  • Via Álvaro Del Portillo, 200
    • Rome, Via Álvaro Del Portillo, 200, Italy, 00128
      • Recruiting
      • Università Campus Biomedico Roma
      • Contact: Gian Paolo Ussia, Prof.; Email: g.ussia@unicampus.it
      • Contact: Elisabetta Ricottini, Dr.; Email: E.Ricottini@unicampus.it
      • Principal Investigator: Gian Paolo Ussia, Prof.
• Spain
  • Avda. Ramón Y Cajal 3
    • Valladolid, Avda. Ramón Y Cajal 3, Spain, 47005
      • Recruiting
      • Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
      • Contact: Ignacio J.Amat-Santos, MD, PhD; Phone Number: 0034657923040; Email: ijamat@gmail.com
      • Contact: Carlos Baladrón Zorita; Phone Number: 86571 0034 983 42 00 00; Email: cbaladron@icicor.es
      • Principal Investigator: Ignacio J.Amat-Santos, MD, PhD
  • Junta De Castilla Y LeónPaseo De San Vicente
    • Salamanca, Junta De Castilla Y LeónPaseo De San Vicente, Spain, 58-182, 37007
      • Recruiting
      • Complejo Hospitalario de Salamanca
      • Contact: Ignacio Cruz Gonzalez, MD, PhD; Phone Number: 0034 687 425 695; Email: i.cruz@usal.es
      • Contact: Nuria Sanchez Barbero; Phone Number: 55789 0034923291100; Email: nsanchezb@saludcastillayleon.es
      • Principal Investigator: Ignacio Cruz Gonzalez, MD, PhD
• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 1ES
      • Recruiting
      • University Hospitals Sussex NHS Foundation Trust Clinical Research Facility
      • Principal Investigator: David Hildick-Smith
      • Contact: David Hildick-Smith; Phone Number: 4049 0044(0)1273 696955; Email: david.hildick-smith@nhs.net
      • Contact: Alison Porges; Phone Number: 63284 0044(0)1273 696955; Email: alison.porges@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age or older
2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
3. At increased risk of stroke or systemic embolism defined as CHADS2 score (Risk of Stroke with AF". VA Palo Alto Medical Center and at Stanford University: the Sportsmedicine Program and the Cardiomyopathy Clinic: Congestive/Hypertension/Age/Diabetes/Stroke): ≥ 2 or a CHA2DS2-VASc score (Congestive/Hypertension/Age/Diabetes/Stroke/Vascular disease/Sex) ≥ 3
4. Deemed, by investigator, to be unsuitable or contraindicated for long term oral anticoagulation therapy due to high bleeding risk
5. To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
6. Able and willing to comply with the required medication regimen post-device implant
7. Able to understand and willing to provide written informed consent to participate in the study
8. Able to and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

1. Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation
2. Contraindicated for or allergic to aspirin/clopidogrel, warfarin or novel oral anticoagulant (NOAC) use
3. Implanted with a mechanical heart valve prosthesis thus requiring long term oral anticoagulation
4. 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)
5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
6. Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
7. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to implant, or intervention or surgery is planned within 60 days after implant procedure
8. Myocardial infarction (MI) within 90 days prior to implant
9. New York Heart Association Class IV Congestive Heart Failure
10. Left ventricular ejection Fraction (LVEF) ≤ 30%
11. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
12. Left atrial appendage is obliterated or surgically ligated
13. Resting heart rate >110 bpm
14. Thrombocytopenia (defined as < 70,000 platelets/mm3) or anaemia with haemoglobin concentration of < 10 g/dl (i.e. anaemia as determined by the investigator which would require transfusion)
15. Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
16. Active endocarditis or other infection producing bacteraemia
17. Subject has a known malignancy or other illness where life expectancy is less than 2 years
18. Impaired renal function with eGFR (Estimated Glomerular Filtration Rate) <40 ml/min/1.73 m2
19. More than mild hepatic failure, i.e. ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), or Alkalic Phosphatase >2× upper limit of normal

Echocardiographic Exclusion Criteria:

1. Intracardiac thrombus - including Left Atrial Appendage - visualized by echocardiographic imaging
2. Existing circumferential pericardial effusion >2mm
3. Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)
4. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (atrial septal excursion >15mm; excursion defined as maximal protrusion of the ASA (Atrial Septal Aneurysm) beyond the plane of the atrial septum during cardiac cycle) or large shunt (substantial passage of bubbles, i.e. ≥ 25, within 3 cardiac cycles from appearing in the right atrium)
5. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
6. Cardiac tumour
7. Left Atrial Appendage anatomy cannot accommodate an Omega™ device (as per IFU)
8. Placement of the device would interfere with any intracardiac or intravascular structure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One arm; Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LAA (Left Atrial Appendage) closure	The 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	According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards)
Device related complications	Serious adverse events (SAE)	According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related complications	All Serious Adverse Events	Up to 7 days post-procedure
Device-related complications	All Serious Adverse Events including device thrombus	24 months
Major bleeding	Major bleeding defined as ≥ BARC (Bleeding Academic Research Consortium) 3 bleed	24 months
Ischemic stroke	Confirmed by Neurologic assessment and appropriate CT (Computed Tomography)/MR (Magnetic Resonance) imaging	24 months
Systemic embolism	Confirmed by appropriate imaging	24 months
Pericardial effusion/tamponade	Confirmed by appropriate imaging	24 months
Technical success at implant	No device-related complications, occlusion of the left atrial appendage	According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards)
Procedural success	Technical success, no procedure-related complications except uncomplicated (minor) device embolization resolved by percutaneous retrieval during the procedure without surgical intervention or damage to surrounding cardiovascular structures	According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards)

Collaborators and Investigators

• Sponsor: Eclipse Medical Ltd.
• Collaborators: KCRI
• Investigators: Principal Investigator: Horst Sievert, profesor, Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany

Publications and helpful links

General Publications

• 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.

Helpful Links

• Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies
• Impact of clinical and haemodynamic factors on coronary flow reserve and invasive coronary flow capacity in non-obstructed coronary arteries: a patient-level pooled analysis of the DEBATE and ILIAS studies

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): November 17, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: left atrial appendage; LAA occluder; non-valvular atrial fibrillation; occluder; high bleeding risk
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hemorrhage
• Other Study ID Numbers: OMEGA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No