LAAO Versus NOAC in Patients with AF and PCI

NARecruitingINTERVENTIONAL
Enrollment

1,386

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

September 20, 2028

Study Completion Date

September 20, 2029

Conditions
Atrial FibrillationPercutaneous Coronary Intervention
Interventions
DEVICE

The WATCHMAN/WATCHMAN FLX device

Watchman device was an umbrella-shaped, self-expanding, nitinol structure with a porous partial polyethylene terephthalate membrane (160 um mesh) and 10 struts. The membrane portion of the structure faces into the body of the left atrial to block embolization of thrombus and provide scaffolding on which endothelialization can occur. The On July 21st, 2020, the FDA approved the next generation LAAO device, named Watchman FLX. This newiteration of the Watchman LAAO platform offers full capability of recapture and redeployment of the device, decreasedmetallic exposure, an increased number of contact points for sealing, a fully rounded delivery shape, and precision anchors designed to provide optimal device engagement with the LAA.

DRUG

Rivaroxaban + Clopidogre

Previous pivotal trials have shown that in patients with atrial fibrillation and requiring antiplatelet treatment, a NOAC plus clopidogrel regimen was associated with a lower incidence of bleeding events as compared with a warfarin-based triple antithrombotic strategy. Therefore, the current expert opinions and consensus of North American Societies recommend a NOAC plus a P2Y12 inhibitor in patients with AF and PCI. In the present study, Rivaroxaban + Clopidogre are required for 45 days in LAAO group after LAAO.

DRUG

Aspirin + Clopidogrel

Aspirin + Clopidogrel are required from 46 days to 12 months after LAAO.

Trial Locations (1)

710032

RECRUITING

Ling Tao, Xi'an

All Listed Sponsors
lead

Xijing Hospital

OTHER