Clinical trial NCT02954237: AMPLATZER™ Cardiac Plug Observational Post-Approval Study
Official title: AMPLATZER™ Cardiac Plug Observational Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Keywords: Non-valvular atrial fibrillation (NVAF)
Anticoagulant
Warfarin
Stroke
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or relevant event despite taking warfarin.

Brief 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:

1. Patient who meets the current indications and per physician discretion for ACP implant
2. Patient who is ≥ 18 years of age at the time of enrolment
3. Patient who is able to provide written Informed Consent prior to any study related procedures

Exclusion Criteria:

1. Patient who is unable to comply with the follow-up schedule
2. Patient with the presence of intracardiac thrombus
3. Patient with active endocarditis or other infections producing bacteraemia
4. Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding (HAS-BLED score\<3)
5. Patient where placement of the device would interfere with any intracardiac or intravascular structures
6. Patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator
7. Patient with LAA anatomy that does not accommodate a device per the sizing guidelines
8. Patient who has a life expectancy of less than 2 years due to any condition
9. Patient who are currently participating in a clinical investigation that includes an active treatment arm
10. Patient who already had a left atrial appendage closure device implanted prior to the study

Primary outcomes:
measure: Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention
timeFrame: Within 7 days of the procedure
measure: 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
timeFrame: Within 2 years of the procedure
measure: Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
timeFrame: Within 2 years of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zhejiang
country: China
facility: Sir Run Run Shaw Hospital
state: Hangzhou
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Liuting Saint
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Abbott
name: Maren Wagner
role: STUDY_DIRECTOR
References: