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

Send

Updated on 25 October 2022

See if I qualify

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 Identifier	NCT04394546
Sponsor	Boston Scientific Corporation
Last Modified on	25 October 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

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)

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

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

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

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

Learn more

Step 3 Enroll in the clinical study

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

Step 4 Get your study results

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

Browse trials for

transient ischemic attack

left atrial appendage closure

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.

Study Definition

Wikipedia

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