Amplatzer Amulet LAAO vs. NOAC

  • STATUS
    Recruiting
  • End date
    Apr 15, 2029
  • participants needed
    2650
  • sponsor
    Abbott Medical Devices
Updated on 15 June 2021
electrocardiogram
stroke
ischemic stroke
noac
vitamin k
vascular disease
embolism
left atrial appendage occlusion

Summary

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Details
Condition Arrhythmia, Hemorrhage, Atrial Fibrillation, Cerebrovascular accident, Atrial Fibrillation (Pediatric), Stroke, Dysrhythmia, cerebrovascular accidents, strokes, cerebral
Treatment Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
Clinical Study IdentifierNCT04226547
SponsorAbbott Medical Devices
Last Modified on15 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of 3
Eligible for long-term NOAC therapy
Able to comply with the required NOAC medication regimen if randomized to the Control Group
Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in
Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment
years of age or older, or the age of legal consent
Able and willing to return for required follow-up visits and assessments

Exclusion Criteria

Requires long-term OAC therapy for a condition other than AF
Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable)
Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
Indicated for P2Y12 platelet inhibitor for >1 year post-randomization
In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure
Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
Is implanted with a mechanical valve prosthesis
Is implanted with an inferior vena cava filter
History of rheumatic or congenital mitral valve heart disease
Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has active infection or bleeding disorder)
Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer)
Experienced stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization
Underwent catheter ablation for AF or atrial flutter within 60 days prior to randomization
Experienced myocardial infarction within 90 days prior to randomization
New York Heart Association Class IV Congestive Heart Failure
Left ventricular ejection fraction 30% (per most recent assessment)
Symptomatic carotid disease (defined as > 50% lumen diameter narrowing on CTA, MRA, or TCD 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% lumen diameter narrowing
Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale)
Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
History of idiopathic or recurrent venous thromboembolism
LAA is obliterated or surgically ligated
Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 10^9 /L)or anemia (defined as hemoglobin < 10 g/dL) requiring transfusions
Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy)
Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial
Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
Active endocarditis or other infection producing bacteremia
Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
Severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2), but not on dialysis
Life expectancy is less than 2 years in the opinion of the Investigator
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note