NCT06189365Terminated
Amplatzer Amulet China Post Market Study (PMS)
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Reason given: This study was terminated due to the shift in Sponsor's business strategy.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 19 Dec 2023
- Start date
- 30 Jan 2024
- Primary completion date
- 5 Dec 2025
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Atrial fibrillation
- NCT number
- NCT06189365
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
- Has a life expectancy of less than 2 years due to any condition
Other
- With the presence of intracardiac thrombus
- Where placement of the device would interfere with any intracardiac or intravascular structures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | China | Unknown status |
| University of Hong Kong-Shenzhen Hospital | Shenzhen | China | Unknown status |
| Wuhan Asia Heart Hospital | Wuhan | China | Unknown status |
| Xianyang Hospital of Yan'an University | Xianyang | China | Unknown status |
| Xiangya Hospital Zhuzhou Central South University | Zhuzhou | China | Unknown status |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.