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出境医 / 临床实验 / Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology (RECORD)
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology (RECORD)
Study Description
Brief 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-valvular Atrial Fibrillation | Device: WATCHMAN LAA occluder | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1050 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology |
| Estimated Study Start Date : | April 20, 2019 |
| Estimated Primary Completion Date : | April 20, 2021 |
| Estimated Study Completion Date : | April 20, 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention group
WATCHMAN LAA occluder treatment
|
Device: WATCHMAN LAA occluder
WATCHMAN LAA occluder
|
Outcome Measures
Primary Outcome Measures :
- The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death [ Time Frame: 12 months post procedure ]
Secondary Outcome Measures :
- Bleeding [ Time Frame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure ]Life threatening or disabling, major bleeding and Minor bleeding
- Vascular access-related complications [ Time Frame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure ]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
- Device-related complications [ Time Frame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure ]Device embolization; Device erosion;Clinically significant device interference with surrounding structure;Device thrombus;Device fracture;Device infection/endocarditis/pericarditis;Device perforation/laceration;Device allergy
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Contacts
| Contact: Ling Tao, Ph.D.,M.D. | 86-29-84775183 | lingtao@fmmu.edu.cn | |
| Contact: Yi Liu, Ph.D.,M.D. | 86-29-84775183 | liuyimeishan@hotmail.com |
Locations
| China, Shanxi | |
| Ling Tao | |
| Xi'an, Shanxi, China, 710054 | |
| Contact: Ling Tao, MD, PhD | |
Sponsors and Collaborators
Xijing Hospital
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, School of Medicine, Zhejiang University
Ningbo No. 1 Hospital
Sir Run Shaw Hospital
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Wuhan Union Hospital, China
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
Investigators
| Principal Investigator: | Ling Tao | Xijing Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 14, 2019 | ||||||||
| First Posted Date ICMJE | April 17, 2019 | ||||||||
| Last Update Posted Date | April 17, 2019 | ||||||||
| Estimated Study Start Date ICMJE | April 20, 2019 | ||||||||
| Estimated Primary Completion Date | April 20, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death [ Time Frame: 12 months post procedure ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology | ||||||||
| Official Title ICMJE | Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology | ||||||||
| Brief 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 | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Non-valvular Atrial Fibrillation | ||||||||
| Intervention ICMJE | Device: WATCHMAN LAA occluder
WATCHMAN LAA occluder
|
||||||||
| Study Arms ICMJE | Experimental: Intervention group
WATCHMAN LAA occluder treatment
Intervention: Device: WATCHMAN LAA occluder
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
1050 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 20, 2024 | ||||||||
| Estimated Primary Completion Date | April 20, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03917563 | ||||||||
| Other Study ID Numbers ICMJE | KY20182078-X-1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Xijing Hospital | ||||||||
| Study Sponsor ICMJE | Xijing Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Xijing Hospital | ||||||||
| Verification Date | April 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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