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The primary objective of this study is to observe the safety and effectiveness of the WATCHMAN FLXâ„¢ Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation to reduce the risk of stroke in Hong Kong area.
This study is a prospective, non-randomized, multi-center observational study. The primary Effectiveness Endpoint is the occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up.The primary safety endpoint is the occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Secondary effectiveness endpoint is the occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The WATCHMAN FLX Delivery System | Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The WATCHMAN FLX Delivery System | Device | WATCHMAN FLX Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | The occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up. | First Follow-up (30 ~ 100 days); |
| Primary Safety Endpoint | The occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are excluded from this endpoint. | First Follow-up (30-100 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | The occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant. | 12-Month Follow-up (365 ± 30 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with non-valvular atrial fibrillation to reduce the risk of stroke
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| Name | Affiliation | Role |
|---|---|---|
| Chan Chin Pang Gary | Prince of Wales Hospital | Principal Investigator |
| Fung Chi Yan Raymond | Princess Margaret Hospital, Canada | Principal Investigator |
| Tsui Kin Lam | Pamela Youde Nethersole Hospital | Principal Investigator |
| Simon Lam | Queen Mary Hospital, Hong Kong | Principal Investigator |
| SF Chui | The Queen Elizabeth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | China |
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Subjects who meet the eligibility criteria, have signed and dated the Informed Consent Form and actually undergo a WATCHMAN FLX implant procedure are considered enrolled in the study. Baseline data from subjects who meet the eligibility criteria, have signed and dated the Informed Consent Form but do not eventually undergo a WATCHMAN FLX implant procedure are collected for epidemiological reasons, to better characterize the population.
WATCHMAN FLX HK study completed FPI on 19 Jun 2020, and completed LPI on 8 Oct 2021, took almost 16 months to complete recruiting 50 patients. There are 50 subjects enrolled in study.
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| ID | Title | Description |
|---|---|---|
| FG000 | The Subjects Who Complete the Study | Subjects who sign informed consent, meets eligibility criteria and successfully implanted with the WATCHMAN FLX device and complete the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The Subjects With No-valvular Atrial Fibrillation Who Implant the WATCHMAN FLX LAAC. | Subjects who meet the eligibility criteria, have signed and dated the Informed Consent Form and actually undergo a WATCHMAN FLX implant procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Effectiveness Endpoint | The occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up. | A total of 46 participants completed the first follow up and belong to PPS set. | Posted | Number | 95% Confidence Interval | percentage of occurence | First Follow-up (30 ~ 100 days); |
|
|
0-12months post LAAC.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Subjects Who Are Attempted or Implanted the WATCHMAN FLX LAAC | The subjects with no-valvular atrial fibrillation who are attempted or implanted the WATCHMAN FLX Left Atrial Appendage Closure (LAAC). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial haemorrhage | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Clinical Trial Manager | Boston Scientific Corperation | +861085742971 | yifan.zhao@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2021 | Jul 18, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2021 | Jul 18, 2022 | SAP_001.pdf |
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| years |
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| Sex/Gender, Customized | Number | participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Primary Safety Endpoint | The occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are excluded from this endpoint. | T | Posted | Number | 95% Confidence Interval | percentage of occurence | First Follow-up (30-100 days) |
|
|
|
| Secondary | Secondary Endpoint | The occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant. | A total of 46 participants belong to PPS set and 50 participants belong to ITT set. | Posted | Number | participants | 12-Month Follow-up (365 ± 30 days) |
|
|
|
| 3 |
| 50 |
| 23 |
| 50 |
| 3 |
| 50 |
| urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Pheumonia | Infections and infestations | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Convulsion (Facial & Limb Twitching) | Nervous system disorders | Systematic Assessment |
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| General weakness | General disorders | Systematic Assessment |
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| Low back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Ischemic Stroke | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
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| Fast Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Right leg involuntary movement | Nervous system disorders | Systematic Assessment |
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| Eseherichia coli septicaemia | Infections and infestations | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
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| Malignant Urethral tumor | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Right groin wound oozing, postoperative | General disorders | Systematic Assessment |
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| Diverticulosis of colon | Gastrointestinal disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Acute decompensated heart failure (ADHF) | Cardiac disorders | Systematic Assessment |
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| Bleeding from the HD Catheter Site | General disorders | Systematic Assessment |
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| Cardiac Chest Pain | Cardiac disorders | Systematic Assessment |
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| Chronic Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Collapse of lumbar vertebra | Injury, poisoning and procedural complications | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| fever | General disorders | Systematic Assessment |
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| Heart Failure | Cardiac disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| INTRACEREBRAL HEMORRHAGE (ICH) | Nervous system disorders | Systematic Assessment |
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| Irreducible Left Inguinoscrotal Hernia | Gastrointestinal disorders | Systematic Assessment |
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| Ischaemic Cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| Ischaemic Heart Disease | Cardiac disorders | Systematic Assessment |
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| Malignant rectal poylp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Parotid Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Postmenopausal bleeding | Reproductive system and breast disorders | Systematic Assessment |
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| right leg swelling | General disorders | Systematic Assessment |
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| Subdural Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| ncope | Nervous system disorders | Systematic Assessment |
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| Todd's paralysis | Nervous system disorders | Systematic Assessment |
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| Wound Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Drug Allergy | Immune system disorders | Systematic Assessment |
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| Abrasion wound (Shaving) | Injury, poisoning and procedural complications | Systematic Assessment |
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| chest pain of unknown etiology | General disorders | Systematic Assessment |
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| COVID-19 infection | Infections and infestations | Systematic Assessment |
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| Ischaemic Heart Disease | Cardiac disorders | Systematic Assessment |
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| Thrombus | Vascular disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tuberculosis of Lung | Infections and infestations | Systematic Assessment |
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| Chronic Gastric Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Chalazion | Eye disorders | Systematic Assessment |
|
| Sprain foot | Injury, poisoning and procedural complications | Systematic Assessment |
|
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