Atrial FibrillationCREWNCT03014557
China REgistry of WATCHMAN
An observational study of Atrial Fibrillation and Left Atrial Appendage Closure, run by Fu Wai Hospital, Beijing, China at 1 site in China.
Trial summary
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Closure
- What is being tested?
- left atrial appendage closure device implantation
- Type of treatment
- Medical device
- How many people
- 413 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: non-valvular atrial fibrillation
Who may be able to join
- Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:
- not suitable for long-term anti-coagulation therapy;
- stroke or embolism events in spite of warfarin treatment with intended INR
- HAS-BLED≥3
Who cannot join
- Patient with any one of the following items will be excluded from the study:
- 1. clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life < 5 years
- 2 Echocardiography exclusion criteria (any of the items) a LVEF<30% b thrombus or spontaneous echo imaging detected within two days prior to procedure c patent foramen ovale d cardiac tumor e left atrial appendage orifice diameter >32mm or < 17mm f the depth of left atrial appendage is less than the width g prominent mitral stenosis (area <1.5cm2)
- 3 subject is not able to or will not complete the follow ups as planned
Trial locations and contacts
1 site in 1 country.
Zhengqin Zhai, MD PhD contact
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing
Zhengqin Zhai, MD PhD, 384358085@qq.com
About this study
Official title: China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.
Read the detailed description
In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure
- Being tested
- left atrial appendage closure device implantation
- Keywords
- atrial fibrillation, left atrial appendage closure, WATCHMAN
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left atrial appendage closure device implantationDevice
to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach
| Study group | Role | What they receive |
|---|---|---|
| WATCHMAN | subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device Receives: Device: left atrial appendage closure device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death, ischemic stroke, systemic embolism, or device or procedure related events
events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.
Measured: between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later
composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.
Measured: 2 years
Secondary outcomes (4)
Implantation success rate.
Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary.
Measured: procedure
Ischemic stroke or systemic embolism
Measured: excluding the first 7 days post enrollment.
All Major Complications.
Major complication is defined as death, stroke, MI or any other serious adverse events related to the device or procedure.
Measured: up to 5 years
All-cause death.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 413 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Shu Zhang, Fu Wai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014557
- Sponsor's protocol ID
- T2016-ZX021
- Acronym
- CREW
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03014557
- Acronym / sponsor ID
- CREW / T2016-ZX021
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure
- Keywords
- atrial fibrillation, left atrial appendage closure, WATCHMAN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 413 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Nov 2016
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.
Detailed description
In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WATCHMAN | – | Device: left atrial appendage closure device implantationsubjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- non-valvular atrial fibrillation
Key inclusion criteria (4 listed)
- Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:
- not suitable for long-term anti-coagulation therapy;
- stroke or embolism events in spite of warfarin treatment with intended INR
- HAS-BLED≥3
Key exclusion criteria (4 listed)
- 1. clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life < 5 years
- 2 Echocardiography exclusion criteria (any of the items) a LVEF<30% b thrombus or spontaneous echo imaging detected within two days prior to procedure c patent foramen ovale d cardiac tumor e left atrial appendage orifice diameter >32mm or < 17mm f the depth of left atrial appendage is less than the width g prominent mitral stenosis (area <1.5cm2)
- 3 subject is not able to or will not complete the follow ups as planned
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 |
|---|---|---|
| left atrial appendage closure device implantationto permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach | Device | WATCHMAN |
Primary outcome
all-cause death, ischemic stroke, systemic embolism, or device or procedure related events
Time frame: between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later
events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.
composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.
Time frame: 2 years
4 secondary outcomes
Implantation success rate.
Time frame: procedure
Ischemic stroke or systemic embolism
Time frame: excluding the first 7 days post enrollment.
All Major Complications.
Time frame: up to 5 years
All-cause death.
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Zhengqin Zhai, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Left Atrial Appendage Closure, run by Fu Wai Hospital, Beijing, China at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengqin Zhai, MD PhD (384358085@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death, ischemic stroke, systemic embolism, or device or procedure related events (time frame: between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later). The study lists 2 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 9 Jan 2017.