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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04394546




Registration number
NCT04394546
Ethics application status
Date submitted
14/05/2020
Date registered
19/05/2020

Titles & IDs
Public title
CHAMPION-AF Clinical Trial
Scientific title
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation
Secondary ID [1] 0 0
S2437
Universal Trial Number (UTN)
Trial acronym
CHAMPION-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Bleeding 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WATCHMAN FLX LAAC Device
Treatment: Drugs - Non-Vitamin K Oral Anticoagulant

Experimental: Device Group - Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device

Active comparator: Control Group - Randomized to non-vitamin K oral anticoagulant (NOAC)


Treatment: Devices: WATCHMAN FLX LAAC Device
WATCHMAN FLX LAAC Device Implantation

Treatment: Drugs: Non-Vitamin K Oral Anticoagulant
Initiation or continuation of a NOAC drug
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism
Timepoint [1] 0 0
36-months
Primary outcome [2] 0 0
WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
Timepoint [2] 0 0
36-months
Primary outcome [3] 0 0
WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism
Timepoint [3] 0 0
60-months
Secondary outcome [1] 0 0
The occurrence of ISTH major bleeding
Timepoint [1] 0 0
60-months
Secondary outcome [2] 0 0
The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
Timepoint [2] 0 0
60-months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

* 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
Accrual to date
Final
3000
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital-Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Westmead Hospital - Bella Vista
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
- Bella Vista
Recruitment outside Australia
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Leicester
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marty Leon, MD
Address 0 0
New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04394546