WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation (CHAMPION-AF)

  • STATUS
    Recruiting
  • End date
    Dec 25, 2027
  • participants needed
    3000
  • sponsor
    Boston Scientific Corporation
Updated on 25 October 2022
Investigator
Kellie Windle
Primary Contact
Centracare Heart and Vascular Center (2.1 mi away) Contact
+140 other location
diabetes
hypertension
stroke
heart failure
anticoagulants
fibrillation
noac
vitamin k
vascular disease
transient ischemic attack
left atrial appendage closure

Summary

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Description

This study is a prospective, randomized, multi-center global investigation. Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device ("Device Group") or a commercially available non-vitamin K oral anticoagulant ("Control Group").

Details
Condition Atrial Fibrillation, Stroke, Bleeding
Treatment WATCHMAN FLX LAAC Device, Non-Vitamin K Oral Anticoagulant
Clinical Study IdentifierNCT04394546
SponsorBoston Scientific Corporation
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject is of legal age to participate in the study per the laws of their respective geography
The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)
The subject has a calculated CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score of 2 or greater for men and 3 or greater for women
The subject is deemed to be suitable for the protocol-defined pharmacologic regimens in both the test and control arms
The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
The subject is able and willing to return for required follow-up visits and examinations

Exclusion Criteria

Subjects who are currently enrolled in another investigational study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy)
The subject is contraindicated or allergic to oral anticoagulation medication and/or aspirin
The subject is indicated for chronic P2Y12 platelet inhibitor therapy
The subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, etc.)
The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment
The subject had a prior major bleeding event per ISTH definition within the 30 days prior to randomization. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event
The subject has an active bleed
The subject has a reversible cause of AF or transient AF
The subject is absent of a left atrial appendage (LAA) or the LAA is surgically ligated
The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment
The subject has a history of atrial septal repair or has an atrial septal device (ASD)/patent foramen ovale (PFO) device
The subject has an implanted mechanical valve prosthesis in any position
The subject has a known contraindication to percutaneous catheterization procedure
The subject has a known contraindication to transesophageal echo (TEE)
The subject has a cardiac tumor
The subject has signs/symptoms of acute or chronic pericarditis
The subject has an active infection
There is evidence of tamponade physiology
The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
The subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment upon study physician's discretion)
The subject has a documented life expectancy of less than 3 years
Transthoracic Echo Exclusion Criteria
The subject has left ventricular ejection fraction ( LVEF) < 30%
The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm
The subject has a high-risk PFO with an atrial septal aneurysm excursion > 15mm or length > 15mm
The subject has significant mitral valve (MV) stenosis (i.e., MV area <1.5 cm2)
Clear my responses

How to participate?

Step 1 Connect with a study center
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

Primary Contact

site

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