The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonablealternative to non-vitamin K oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation.
ID
Source
Brief title
Condition
- Other condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Cardiac arrhythmias
Synonym
Health condition
non-valvular atrial fibrillation
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. WATCHMAN FLX is non-inferior for the occurrence of stroke (including
ischemic and/or hemorrhagic), cardiovascular (CV) death (including hemorrhagic
and/or unexplained death), and systemic embolism at 36-months. This endpoint is
defined as the Kaplan Meier estimate of time to first
occurrence of stroke (including ischemic and/or hemorrhagic), all CV death, or
systemic embolism at 36 months.
2. WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding
and clinically relevant non-major bleeding) at 36-months. This endpoint is
defined as the Kaplan Meier estimate of time to first occurrence of
non-procedural ISTH major bleeding or clinically relevant nonmajor
bleeding through 36- months.
Secondary outcome
The occurrence of ISTH major bleeding at 36-months. First test NI at 36-months,
if passed then test for superiority at 60-months.
The occurrence of cardiovascular (CV) death, disabling stroke, systemic
embolism (SE), and non-procedural bleeding (ISTH major bleeding and
clinically relevant non-major bleeding) at 36-months. First test NI at
36-months, if passed then test for superiority at 60-months.
Background summary
As the risk of stroke increases with age and the disability and tolerance
concerns with available drug therapies persist, the need for permanent
protection against thromboembolism in AF patients remains unmet. The sponsor
developed the WATCHMANTM and WATCHMAN FLXTM Left Atrial Appendage Closure
(LAAC) Devices, permanent implantable devices designed to seal off the left
atrial appendage (i.e., the location where the
Study objective
The primary objective of this study is to determine if left atrial appendage
closure with the WATCHMAN FLX device is a reasonable
alternative to non-vitamin K oral anticoagulants (NOACs) in patients with
non-valvular atrial fibrillation.
Study design
This study is a prospective, randomized, multi-center global investigation to
determine if left atrial appendage closure with the
WATCHMAN FLX Device is a reasonable alternative to NOACs in patients with
non-valvular atrial fibrillation.
Intervention
Patients will undergo a standard treatment
Study burden and risks
Both treatments are used in standard of care
Boston Scientific International SA Parc Val Saint-Quentin, Bâtiment H, 2 Rue René Caudron
Voisins le Bretonneux, 78960
FR
Boston Scientific International SA Parc Val Saint-Quentin, Bâtiment H, 2 Rue René Caudron
Voisins le Bretonneux, 78960
FR
Listed location countries
Age
Inclusion criteria
1. The subject is of legal age to participate in the study per the laws of
their respective geography
2. 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)
3. The subject has a calculated CHA2DS2-VASc score of 2 or greater
for men and 3 or greater for women
4. The subject is deemed to be suitable for the protocol defined
pharmacologic regimens in both the test and control arms
Exclusion criteria
1.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)
3. The subject is contraindicated or allergic to oral anticoagulation
medication and/or aspirin
4. The subject is indicated for chronic P2Y12 platelet inhibitor therapy
5. 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.)
6. 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
7. 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
8. The subject has an active bleed
9. The subject is of childbearing potential and is, or plans to become,
pregnant during the time of the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75294.100.20 |
| Other | to be notified |