Status:
TERMINATED
Amplatzer Amulet China Post Market Study (PMS)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Non-Valvular Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.
Detailed Description
Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. During AF, chaotic electrical activity results in rapid, uncoordinated, and insufficient contractions of the atrial chamber...
Eligibility Criteria
Inclusion
- Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events
- Meets the current device indications and per physician discretion for Amulet implant
- Able to provide written Informed Consent prior to any study related procedures
- 18 years of age or older at the time of enrolment
Exclusion
- With the presence of intracardiac thrombus
- With active endocarditis or other infections producing bacteremia
- Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score \< 3)
- Where placement of the device would interfere with any intracardiac or intravascular structures
- Has a life expectancy of less than 2 years due to any condition
- Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial
Key Trial Info
Start Date :
January 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 5 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06189365
Start Date
January 30 2024
End Date
December 5 2025
Last Update
December 18 2025
Active Locations (5)
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1
University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China, 518009
2
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
3
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
4
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, Hunan, China, 412007