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Atrial FibrillationNCT03526471

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

A study testing Omega™ Left Atrial Appendage (LAA) Occluder in people with Atrial Fibrillation, run by Vascular Innovations Co. Ltd. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Omega™ Left Atrial Appendage (LAA) Occluder
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
1 Jun 2019to 31 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 60 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.

Who cannot join

  • 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)
Show all 31Show fewer
  • 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
  • Resting heart rate >110 bpm
  • 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)
  • 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 <40 ml/min/1.73 m2
  • More than mild hepatic failure, i.e. ALT, AST, or Alkalic Phosphatase >2× upper limit of normal
  • Echocardiographic Exclusion Criteria:
  • Intracardiac thrombus - including LAA - visualized by echocardiographic imaging
  • Existing circumferential pericardial effusion >2mm
  • Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)
  • High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (atrial septal excursion >15mm; excursion defined as maximal protrusion of the ASA 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)
  • Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
  • Cardiac tumour
  • LAA anatomy cannot accommodate an Omega™ device (as per IFU)
  • Placement of the device would interfere with any intracardiac or intravascular structure.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Thailand1 site

  • Chulalongkorn University

    Pathum Wan, Bangkok, 12000

Other trials in Thailand

About this study

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

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.

Read the detailed description

This is a single arm study to assess the safety and performance of the Omega™ Left Atrial Appendage (LAA) Occluder in patients with Non-valvular atrial fibrillation (NVAF) and high bleeding risk.

The study will be conducted in accordance with the ISO standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice) and other legal requirements as applicable.

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.

The primary safety endpoint of the study is device-related complications (serious adverse events [SAEs]) through 60 days (+/- 15 days) post-procedural.

Following consent a number of assessments will be undertaken prior to the procedure to ensure the study eligibility criteria are met. These assessments include; medical history, physical exams, ECG, blood tests, transthoracic echocardiogram, transesophageal echocardiogram and cardiac CT.

The implant procedure will usually be performed under general anaesthetic. A thin catheter is inserted in the femoral vein in the right groin area and advanced under X-Ray guidance to the right atrium, then a very small needle is used to cross through to the left atrium to allow the delivery catheter to place the Omega in the Appendage, guided by both X-Ray and transesophageal echo. A medication regimen for endocarditis prophylaxis anticoagulation is recommended post procedure.

Following discharge, patients will be seen again at 60 days, 6 months and 12 months to collect data for the primary performance endpoint (by TTE or TEE) and safety endpoints (mRS, stroke/TIA assessments, and ECG).

An interim analysis is planned following the collection of 60 day data for the first 10 patients implanted with the device. An additional interim analysis will be performed following the collection of 60 days (+/- 15 days) data for the first 50 patients implanted with the device.

Final analysis will be performed once all 150 subjects have been implanted with the device and completed the study to further document and confirm the safety and effectiveness of the device.

Being tested
Omega™ Left Atrial Appendage (LAA) Occluder
Keywords
Left Atrial Appendage, Non-valvular atrial fibrillation, High Bleeding Risk
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega™ Left Atrial Appendage (LAA) OccluderDevice

    catheter delivery of Omega device in the left atrial appendage

Study groups in NCT03526471
Study groupRoleWhat they receive
Left Atrial Appendage (LAA) OccluderExperimentalLeft Atrial Appendage (LAA) Occluder
Receives: Device: Omega™ Left Atrial Appendage (LAA) Occluder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LAA closure

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

    Measured: at 60 days (+/- 15 days)

  2. Device-related complications

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

    Measured: through 60 days post-procedure

Secondary outcomes (7)

  1. Procedure-related complications

    Meeting the serious adverse event criteria set out in the protocol and being assessed as related to the study procedure.

    Measured: 1 to 6 days post-procedure

  2. Major bleeding

    Defined as ≥ BARC 3 bleed

    Measured: From procedure to 12 months

  3. Ischemic stroke

    Confirmed by Neurologic assessment and appropriate CT/MR imaging

    Measured: From procedure to 12 months

  4. Systemic embolism

    Confirmed by appropriate imaging.

    Measured: From procedure to 12 months

  5. Pericardial effusion/tamponade

    Per protocol

    Measured: From procedure to 12 months

  6. Technical success

    Composite of: Occlusion of the LAA, No device-related complications, No leak >5mm on colour Doppler Transesophageal Echocardiography (TEE),

    Measured: At implant

  7. Procedural success

    Composite of: 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.

    Measured: At procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study start1 Jun 2019
  3. Primary completion30 Jan 2020
  4. Study completion31 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03526471
Sponsor's protocol ID
LAAC
Status last verified
Aug 2020
First submitted
3 May 2018
Last updated
27 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Omega™ Left Atrial Appendage (LAA) Occluder in people with Atrial Fibrillation, run by Vascular Innovations Co. Ltd. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LAA closure (time frame: at 60 days (+/- 15 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03526471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.

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