Informations générales (source: ClinicalTrials.gov)
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation (CHAMPION-AF)
Interventional
N/A
Boston Scientific Corporation (Voir sur ClinicalTrials)
octobre 2020
décembre 2027
19 juin 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Grenoble-Hopital Michallon - 38043 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Hopital Cardiologique de Lyon - Bron - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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)