N/A
N=91
AMPLATZER™ Cardiac Plug Observational Post-Approval Study
Non-valvular Atrial Fibrillation (NVAF)
Bottom Line
View on ClinicalTrials.gov: NCT02954237 ↗Enrolled (actual)
91
Serious AEs
30.8%
Results posted
Jun 2022
Primary outcome: Primary: Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention — 1.1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AMPLATZER™ Cardiac Plug (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention |
1.1 | — |
| PRIMARY Long-Term Safety Endpoint: Composite Rate of Device Embolization/Device Erosion/Device Interference With Surrounding Structure/Device Thrombus/Device Fracture/Device Infection/Device Perforation/Device Laceration/Device Allergy |
2.2 | — |
| PRIMARY Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism |
1.1 | — |
Summary
The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single arm, post approval, observational study. The clinical study will be conducted at up to 35 sites in China. Approximately 343 subjects will be enrolled in this study.
The total study duration is expected to be approximately 7 years. The study population included patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or other thromboembolic event despite taking warfarin.
Scheduled office visits occur at 45 days (+45 days), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and 24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6 weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.
Eligibility Criteria
Inclusion Criteria
- Patient who meets the current indications and per physician discretion for ACP implant
- Patient who is ≥ 18 years of age at the time of enrolment
- Patient who is able to provide written Informed Consent prior to any study related procedures
Exclusion Criteria
- Patient who is unable to comply with the follow-up schedule
- Patient with the presence of intracardiac thrombus
- Patient with active endocarditis or other infections producing bacteraemia
- Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding (HAS-BLED score<3)
- Patient where placement of the device would interfere with any intracardiac or intravascular structures
- Patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator
- Patient with LAA anatomy that does not accommodate a device per the sizing guidelines
- Patient who has a life expectancy of less than 2 years due to any condition
- Patient who are currently participating in a clinical investigation that includes an active treatment arm
- Patient who already had a left atrial appendage closure device implanted prior to the study
Data sourced from ClinicalTrials.gov (NCT02954237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.