Overview

A Multi-center RCT Trial on Prognosis of Patients With Anticoagulation and DAPT Therapy After LAAC

Status:
Unknown status
Trial end date:
2020-11-30
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to assess the different dosage of rivaroxaban application versus dual antiplatelet therapy for prevention of device-related-thrombus in patients undergoing left atrial appendage closure using the WATCHMAN device.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Zhongshan Hospital
Treatments:
Rivaroxaban
Criteria
Inclusion Criteria:

- Successful transcatheter LAAC with any approved device

- Age18-75 years old

- Weight≥50kg

Exclusion Criteria:

- Absolute contraindications for anticoagulation therapy

- Prior intracranial hemorrhage

- Contraindications for TEE

- Severe pericardial effusion within the first 24 hrs following LAAC

- Major/life-threatening bleeding within the first 24 hrs following LAAC

- Female subjects of childbearing potential without using highly effective methods of
contraception

- Serious renal insufficiency(CRCL<30ml/min)