Non-valvular Atrial FibrillationRECORDNCT03917563
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
A study testing WATCHMAN LAA occluder in people with Non-valvular Atrial Fibrillation, run by Xijing Hospital at 1 site in China.
Trial summary
The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- WATCHMAN LAA occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2019to 20 Apr 2024
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years of age or above;
- Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
- Patient is willing and capable of providing informed consent to participate in all procedures associated with receiving a WATCHMAN device at an approved clinical investigational center.
Who cannot join
- Patient is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
- Patient is a woman of childbearing potential who is, or plans on becoming, pregnant during the duration of follow-up assessments required as part of the WATCHMAN procedure.
- Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- WATCHMAN LAA occluder
- Keywords
- atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMAN LAA occluderDevice
WATCHMAN LAA occluder
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | WATCHMAN LAA occluder treatment Receives: Device: WATCHMAN LAA occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
Measured: 12 months post procedure
Secondary outcomes (3)
Bleeding
Life threatening or disabling, major bleeding and Minor bleeding
Measured: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Vascular access-related complications
Haematoma at access site<6 cm; Retroperitoneal haematoma;Arteriovenous fistula;Vascular surgical repair at catheter access sites;Pulmonary embolism;Ipsilateral deep vein thrombosis;Access site-related infection requiring intravenous antibiotics or extended hospitalization
Measured: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Device-related complications
Device embolization; Device erosion;Clinically significant device interference with surrounding structure;Device thrombus;Device fracture;Device infection/endocarditis/pericarditis;Device perforation/laceration;Device allergy
Measured: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start20 Apr 2019 (estimated)
- Primary completion20 Apr 2021 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Hospital, the PLA General Hospital, Beijing Chao Yang Hospital, Peking University First Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 10th People's Hospital, Changhai Hospital, Dongfang Hospital Affiliated to Tongji University, Shanghai 6th People's Hospital, Ruijin Hospital, Shanghai Thoracic Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shenzhen Sun Yat-sen Cardiovascular Hospital, Tianjin Medical University General Hospital, Southwest Hospital, China, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Central Hospital of Dalian, General Hospital of Shenyang Military Region, Qilu Hospital of Shandong University, The Second Hospital of Hebei Medical University, Shanxi Cardiovascular Hospital, People's Hospital of Taizhou, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital, Zhejiang University, School of Medicine, Ningbo No. 1 Hospital, Sir Run Shaw Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Asia Heart Hospital, First Affiliated Hospital Xi'an Jiaotong University, General Hospital of Ningxia Medical University, Sichuan Provincial People's Hospital, West China Hospital, ZhuHai Hospital, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor
- Investigators
- Ling Tao, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917563
- Sponsor's protocol ID
- KY20182078-X-1
- Acronym
- RECORD
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang P, Chen Z, Yan Y, Fu G, Liu J, Zhang R, Ruan Z, Zhao X, Wang H, Tang B, Xie X, Yi F, Bai Y, Zhou X, Zhu J, Hu H, Garg S, Serruys PW, Gao C, Tao L. Effect of Fluoroscopy-Only Versus Transesophageal Echocardiography/Intracardiac Echocardiography Guidance in Left Atrial Appendage Occlusion on Stroke Prevention: Analysis From the RECORD I Study. J Am Heart Assoc. 2026 Jul 21;15(14):e049309. doi: 10.1161/JAHA.126.049309. Epub 2026 Jul 10.
PubMed 42432454Gao C, Su F, Liu J, Zhang T, Ning Z, Yang B, Chu H, He B, Zhang J, Zhou L, Li Y, Zhang Y, Hu H, Xu Y, Zeng J, Guo J, Su X, Ruan ZB, Liu H, Wang P, Garg S, Soliman O, Holmes DR Jr, Serruys PW, Tao L; RECORD Investigators. 1-Year Clinical Outcomes and the Impact of Procedural Configurations in Left Atrial Appendage Occlusion Patients. JACC Asia. 2024 Oct 1;4(10):777-790. doi: 10.1016/j.jacasi.2024.07.013. eCollection 2024 Oct.
PubMed 39553900
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
- ClinicalTrials.gov ID
- NCT03917563
- Acronym / sponsor ID
- RECORD / KY20182078-X-1
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Hospital, the PLA General Hospital, Beijing Chao Yang Hospital, Peking University First Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 10th People's Hospital, Changhai Hospital, Dongfang Hospital Affiliated to Tongji University, Shanghai 6th People's Hospital, Ruijin Hospital, Shanghai Thoracic Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shenzhen Sun Yat-sen Cardiovascular Hospital, Tianjin Medical University General Hospital, Southwest Hospital, China, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Central Hospital of Dalian, General Hospital of Shenyang Military Region, Qilu Hospital of Shandong University, The Second Hospital of Hebei Medical University, Shanxi Cardiovascular Hospital, People's Hospital of Taizhou, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital, Zhejiang University, School of Medicine, Ningbo No. 1 Hospital, Sir Run Shaw Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Asia Heart Hospital, First Affiliated Hospital Xi'an Jiaotong University, General Hospital of Ningxia Medical University, Sichuan Provincial People's Hospital, West China Hospital, ZhuHai Hospital, First Affiliated Hospital of Xinjiang Medical University
- Study start
- 20 Apr 2019 (estimated)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 17 Apr 2019 (actual)
- 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.
The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: WATCHMAN LAA occluderWATCHMAN LAA occluder treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is 18 years of age or above;
- Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
- Patient is willing and capable of providing informed consent to participate in all procedures associated with receiving a WATCHMAN device at an approved clinical investigational center.
Key exclusion criteria (3 listed)
- Patient is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
- Patient is a woman of childbearing potential who is, or plans on becoming, pregnant during the duration of follow-up assessments required as part of the WATCHMAN procedure.
- Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.
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 |
|---|---|---|
| WATCHMAN LAA occluderWATCHMAN LAA occluder | Device | Intervention group |
Primary outcome
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
Time frame: 12 months post procedure
3 secondary outcomes
Bleeding
Time frame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Vascular access-related complications
Time frame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Device-related complications
Time frame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 42432454Wang P, Chen Z, Yan Y, Fu G, Liu J, Zhang R, Ruan Z, Zhao X, Wang H, Tang B, Xie X, Yi F, Bai Y, Zhou X, Zhu J, Hu H, Garg S, Serruys PW, Gao C, Tao L. Effect of Fluoroscopy-Only Versus Transesophageal Echocardiography/Intracardiac Echocardiography Guidance in Left Atrial Appendage Occlusion on Stroke Prevention: Analysis From the RECORD I Study. J Am Heart Assoc. 2026 Jul 21;15(14):e049309. doi: 10.1161/JAHA.126.049309. Epub 2026 Jul 10.
- Derived from this study: PubMed 39553900Gao C, Su F, Liu J, Zhang T, Ning Z, Yang B, Chu H, He B, Zhang J, Zhou L, Li Y, Zhang Y, Hu H, Xu Y, Zeng J, Guo J, Su X, Ruan ZB, Liu H, Wang P, Garg S, Soliman O, Holmes DR Jr, Serruys PW, Tao L; RECORD Investigators. 1-Year Clinical Outcomes and the Impact of Procedural Configurations in Left Atrial Appendage Occlusion Patients. JACC Asia. 2024 Oct 1;4(10):777-790. doi: 10.1016/j.jacasi.2024.07.013. eCollection 2024 Oct.
- Individual participant dataSharing planned: Undecided
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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.
Ling Tao principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATCHMAN LAA occluder in people with Non-valvular Atrial Fibrillation, run by Xijing Hospital 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 3 inclusion and 3 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 17 Apr 2019. 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 Ling Tao, Ph.D.,M.D. (86-29-84775183, lingtao@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917563, which also lists 2 linked publications.
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 17 Apr 2019.