Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation

NCT03526471 | Completed

• 1 other identifier: LAAC
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber. Plugging this appendage with an implantable plug type device, which is placed via a catheter painlessly in the femoral vein, has been proven to be a reliable alternative to the standard anti-clotting medication in a number of recent international trials. The Omega device is a new design of such a plug, made from biocompatible and compressible nitinol and fabric. Up to 195 patients will be enrolled in Europe, assuming that enrolment will stop once the Omega™ device has been successfully implanted in 150 evaluable patients. The primary performance endpoint of the study is LAA closure (defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm) at 60 days (+/- 15 days) visit documented by transoesophageal echocardiogram (TEE/TOE) with colour flow Doppler.

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage; Non-valvular atrial fibrillation; High Bleeding Risk

Outcome Measures

Primary Outcomes (2)

• LAA closure

  Complete seal or efficient seal with a peri-device leak ≤ 5 mm documented by transoesophageal echocardiogram (TEE/TOE) with colour flow Doppler.

  at 60 days (+/- 15 days)

• Device-related complications

  Serious adverse event criteria set out in the protocol and being assessed as related to the study device.

  through 60 days post-procedure

Secondary Outcomes (7)

• Procedure-related complications

  1 to 6 days post-procedure

• Major bleeding

  From procedure to 12 months

• Ischemic stroke

  From procedure to 12 months

• Systemic embolism

  From procedure to 12 months

• Pericardial effusion/tamponade

  From procedure to 12 months

Study Arms (1)

Left Atrial Appendage (LAA) Occluder

EXPERIMENTAL

Left Atrial Appendage (LAA) Occluder

Device: Omega™ Left Atrial Appendage (LAA) Occluder

Interventions

Omega™ Left Atrial Appendage (LAA) Occluder DEVICE

catheter delivery of Omega device in the left atrial appendage

Left Atrial Appendage (LAA) Occluder

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 CHADS2 score \> 2 or a CHA2DS2-VASc score \> 3
• Deemed, by investigator, to be unsuitable or contraindicated for long term oral anticoagulation therapy due to high bleeding risk
• To have suitable anatomy for percutaneous LAA occlusion procedure with a single Omega™ device based on CT scan evaluation
• 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
• Able to and willing to return for required follow-up visits and examinations.

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 undergone surgical atrial septal defect (ASD) repair or has an ASD closure device implanted
• Has undergone surgical patent foramen ovale (PFO) repair or has a PFO closure device implanted
• Implanted with a mechanical heart valve prosthesis thus requiring long term oral anticoagulation
• 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)
• Stroke or transient ischemic attack (TIA) within 90 days prior to implant procedure
• 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
• Myocardial infarction (MI) within 90 days prior to implant
• New York Heart Association Class IV Congestive Heart Failure
• Left ventricular ejection Fraction (LVEF) \<30%
• Symptomatic carotid artery disease (defined as \>50% reduced diameter with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \>50% reduced diameter
• Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• History of idiopathic or recurrent venous thromboembolism requiring long term oral anticoagulation
• Left atrial appendage is obliterated or surgically ligated

Sponsors & Collaborators

• Vascular Innovations Co. Ltd.: lead
• MedPass International: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Chulalongkorn University

Pathum Wan, Bangkok, 12000, Thailand

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aidan Mulloy

  Eclipse Medical Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: June 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: March 31, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); DK (1)