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Terminated
NCT06189365
Amplatzer Amulet China Post Market Study (PMS)
Conditions: Non-Valvular Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: Abbott Medical Devices
Location: University of Hong Kong-Shenzhen Hospital Shenzhen Guangdong
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.
Eligibility Criteria
Inclusion Criteria:
1. 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
2. Meets the current device indications and per physician discretion for Amulet implant
3. Able to provide written Informed Consent prior to any study related procedures
4. 18 years of age or older at the time of enrolment
Exclusion Criteria:
1. With the presence of intracardiac thrombus
2. With active endocarditis or other infections producing bacteremia
3. Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score \< 3)
4. Where placement of the device would interfere with any intracardiac or intravascular structures
5. Has a life expectancy of less than 2 years due to any condition
6. 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
Source: ClinicalTrials.gov (NCT06189365). StuddyBuddy aggregates publicly available trial information.