Non-valvular Atrial Fibrillation (NVAF)ACP ChinaNCT02954237
AMPLATZER™ Cardiac Plug Observational Post-Approval Study
An observational study of Non-valvular Atrial Fibrillation (NVAF), run by Abbott Medical Devices at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF)
- What is being tested?
- AMPLATZER™ Cardiac Plug
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 6 sitesChina
- Study dates
- 14 Nov 2016to 29 Jan 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510060
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310006
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Ningbo First Hospital
Ningbo, Liuting Saint, 315000
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430000
Sir Run Run Shaw Hospital
Zhejiang, Hangzhou, 310016
About this study
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.
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Being tested
- AMPLATZER™ Cardiac Plug
- Keywords
- Non-valvular atrial fibrillation (NVAF), Anticoagulant, Warfarin, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER™ Cardiac PlugDevice
The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
| Study group | Role | What they receive |
|---|---|---|
| AMPLATZER™ Cardiac Plug | Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm. Receives: Device: AMPLATZER™ Cardiac Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention
The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention.
Measured: Within 7 days of the procedure
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
The primary long-term safety endpoint was the composite of of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis and pericarditis), device perforation, device laceration, or device allergy.
Measured: Within 2 years of the procedure
Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.
Measured: Within 2 years of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start14 Nov 2016
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-valvular Atrial Fibrillation (NVAF)Studies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maren Wagner, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954237
- Sponsor's protocol ID
- SJM-CIP-CRD 881
- Other IDs
- SJM-CIP-10153
- Acronym
- ACP China
- Status last verified
- Jun 2022
- First submitted
- 10 Oct 2016
- Last updated
- 24 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMPLATZER™ Cardiac Plug Observational Post-Approval Study
- ClinicalTrials.gov ID
- NCT02954237
- Acronym / sponsor ID
- ACP China / SJM-CIP-CRD 881
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Keywords
- Non-valvular atrial fibrillation (NVAF), Anticoagulant, Warfarin, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Posted 24 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMPLATZER™ Cardiac Plug | – | Device: AMPLATZER™ Cardiac PlugSubjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPLATZER™ Cardiac PlugThe AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr) | Device | AMPLATZER™ Cardiac Plug |
Primary outcome
Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention
Time frame: Within 7 days of the procedure
The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention.
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
Time frame: Within 2 years of the procedure
The primary long-term safety endpoint was the composite of of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis and pericarditis), device perforation, device laceration, or device allergy.
Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
Time frame: Within 2 years of the procedure
The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maren Wagner study director
Abbott
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation (NVAF), run by Abbott Medical Devices at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention (time frame: Within 7 days of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.