CHAMPION-AF: WATCHMAN FLX Implant against NOAC (tablets) for protection against embolisms in the treatment of patients with non-valvular atrial fibrillation
Summary description of the study
You are invited to participate in this study because you have a heart condition where the atria of your heart pump irregularly. This condition, also known as atrial fibrillation (or AFib), affects the normal pumping function of the heart. Atrial fibrillation can lead to a slowdown in blood flow in an area of your heart, the left atrial appendage or LAA. The LAA is like a pouch at the top of your heart. An LAA forms before the birth of every person. During an episode of atrial fibrillation, blood clots can form due to the slow blood flow in the LAA. If a blood clot breaks off from the LAA and travels to another part of the body, it can block blood supply. If this part of the body is the brain, it can lead to a stroke. In AFib, there is an increased risk of stroke or other related problems. This study aims to determine whether your AFib can be treated with an LAA closure using the WATCHMAN FLXTM implant instead of blood thinners. This medical device is permanently implanted in the LAA of your heart and closes it. The medications administered in this study are approved in Switzerland. Your investigator will review your medical records to assess your health status and the medications you are taking. He will also ask you questions about your health to check if you meet all the requirements for participation in the study. If you agree to participate, you will be "randomized" either to the MEDICAL DEVICE group or the CONTROL group. Randomization means that you will be assigned to a group randomly, similar to flipping a coin. A computer program will assign you to one of the two study groups (MEDICAL DEVICE or CONTROL). Your data can only be identified by a study code, meaning your participation is confidential.
(BASEC)
Intervention under investigation
Heart disease - Atrial fibrillation
(BASEC)
Disease under investigation
Patients with non-valvular atrial fibrillation
(BASEC)
1. The study participant is of legal age. 2. The study participant has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or more severe mitral stenosis or a mechanical heart valve). 3. The study participant has a calculated CHA2DS2-VASc score of 2 or higher for men and 3 or higher for women. 4. The study participant is considered suitable for the pharmacological treatments defined in the study protocol in both the treatment and control arms. 5. The study participant or legal representative can understand a written informed consent form and is willing to sign it to participate in the study. 6. The study participant is able and willing to present for the required follow-up and further examinations. (BASEC)
Exclusion criteria
1. Patients currently participating in another clinical study, except when the study participant is involved in a mandatory government registration or a purely observational study without treatment. 2. The study participant requires long-term anticoagulation therapy for reasons other than reducing the risk of a stroke associated with atrial fibrillation, for example due to an underlying increased tendency to coagulate (i.e., study participants cannot discontinue anticoagulation therapy due to other conditions requiring chronic anticoagulation therapy during the implantation of the system). 3. Oral anticoagulants and/or aspirin are contraindicated for the study participant or they are allergic to them. 4. Chronic P2Y12 platelet inhibitor treatment is indicated for the study participant. 5. A cardiological or non-cardiological procedure or surgical intervention is planned for the study participant within 30 days before or 60 days after the implant (including: cardioversion, percutaneous coronary intervention (PCI), catheter ablation, cataract surgery, etc.). 6. The study participant had a stroke within 30 days prior to recruitment (of any cause, whether ischemic or hemorrhagic) or a transient ischemic attack (TIA). 7. The study participant had a severe bleeding within 30 days prior to randomization according to the ISTH definition. The absence of resolution of associated clinical complications or planned and pending interventions to address a bleeding / bleeding source is also a reason for exclusion, regardless of the timing of the bleeding. 8. The study participant has active bleeding. 9. The study participant has a reversible case of atrial fibrillation or transient atrial fibrillation. 10. The study participant does not have an LAA or the LAA is surgically ligated. 11. The study participant had a myocardial infarction (MI) within 30 days prior to recruitment, documented in clinical records, either as a non-ST elevation MI (NSTEMI) or as an ST elevation MI (STEMI), with or without intervention. 12. The study participant has a history of atrial septal repair or has an ASD/PFO device. 13. The study participant has an implanted mechanical heart valve prosthesis, regardless of its position. 14. The study participant has a known contraindication to percutaneous catheterization. 15. The study participant has a known contraindication to TEE. 16. The study participant has a cardiac tumor. 17. The study participant shows signs/symptoms of acute or chronic pericarditis. 18. The study participant has an active infection. 19. There are signs of tamponade. 20. The study participant has New York Heart Association class IV heart failure at the time of recruitment. 21. The study participant is of childbearing age and is pregnant or wishes to become pregnant during the study (method of assessment at the discretion of the investigator). 22. The study participant has a documented life expectancy of less than 3 years. (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Sarah Zanon, Boston Scientific Cooperation, 1024 Ecublens
(BASEC)
Contact
Contact Person Switzerland
Kellie Windle, Senior Clinical Trial Manager Boston Scientific Interventional Cardiology
+1 (508) 683-6616
Kellie.Windle@clutterbsci.comBoston Scientific Interventional Cardiology
(BASEC)
General Information
New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center,Virginia Commonwealth University,Pacific Heart Institute and Providence St. John's Health Center,HCA Healthhcare /Los Robles Health System
(ICTRP)
General Information
New York-Presbyterian Heart Valve Center/Columbia University Irving Medical CenterVirginia Commonwealth UniversityPacific Heart Institute and Providence St. John's Health CenterHCA Healthhcare /Los Robles Health System
(ICTRP)
Scientific Information
New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center,Virginia Commonwealth University,Pacific Heart Institute and Providence St. John's Health Center,HCA Healthhcare /Los Robles Health System
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
02.03.2021
(BASEC)
ICTRP Trial ID
NCT04394546 (ICTRP)
Official title (approved by ethics committee)
WATCHMAN FLX versus NOAC for EMbolic ProtectION in the Management of Patients with Non-Valvular Atrial Fibrillation CHAMPION-AF (BASEC)
Academic title
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation (ICTRP)
Public title
CHAMPION-AF Clinical Trial (ICTRP)
Disease under investigation
Atrial FibrillationStrokeBleeding (ICTRP)
Intervention under investigation
Device: WATCHMAN FLX LAAC DeviceDrug: Non-Vitamin K Oral Anticoagulant (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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) (ICTRP)
not available
Primary and secondary end points
WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism;WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding);WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism (ICTRP)
The occurrence of ISTH major bleeding;The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Marty Leon, MD;Kenneth A Ellenbogen, MD;Shephal Doshi, MD;Saibal Kar, MD, New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center,Virginia Commonwealth University,Pacific Heart Institute and Providence St. John's Health Center,HCA Healthhcare /Los Robles Health System (ICTRP)
Secondary trial IDs
S2437 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04394546 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available