Atrial FibrillationNCT03327350
WATCHMAN for Second Prevention of Stroke (WASPS)
An observational study of Atrial Fibrillation and Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of stroke in the patients with nonvalvular atrial fibrillation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- WATCHMAN transplantation and Oral anticoagulant drugs
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2017to Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 400 hospitalized patients over 18 years old with nonvalvular atrial fibrillation will be enrolled consecutively
Who may be able to join
- Age 18 years or older;
- A history of stroke/transient ischemic attack(TIA) over 3 months;
- Paroxysmal, persistent, or permanent nonvalvular AF;
- 4.2 or more CHA2DS2-VASc risk factors
- Eligibility for long-term anticoagulation with warfarin or new oral anticoagulants.
Who cannot join
- patent foramen ovale with atrial septal aneurysm
- an atrial septal defect
- mechanical valve prosthesis
- left ventricular ejection fraction less than 30%
- mobile aortic atheromata
- symptomatic carotid disease
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: The WASPS Trails:WATCHMAN for Second Prevention of Stroke
To evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of stroke in the patients with nonvalvular atrial fibrillation
Read the detailed description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting an estimated 5 million Chinese. Atrial fibrillation is the primary cardiac abnormality associated with embolic stroke; among patients with AF, there is an annual stroke rate, about 5 times for the same age population in sinus rhythm.
Although warfarin therapy is effective at reducing the risk of stroke, chronic anticoagulation presents problems of safety and acceptability for many patients. Drug and dietary interactions, frequent blood tests, and compliance issues all contribute to difficulties with chronic warfarin therapy. New oral anticoagulant compounds with better therapeutic range and without need for similar monitoring, such as Dabigatran, Rivaroxaban, Apixaban and Edoxaban,have been studied, but there is no direct comparison with left atrial appendage closure(LAAC).
However,the left atrial appendage (LAA) is the major location of thrombi in patients with AF. In patients with nonrheumatic AF and thrombus in the left atrium, the clot was located in the LAA in 90%. And the WATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic thromboembolism in patients with AF.The PROTECT-Af and PREVAIL trails confirmed this device's efficacy and safety, compared with warfarin, for preventing the combined outcome of stroke,systemic embolism, and cardiovascular death. And the device has been approved by China's FDA.
Stroke is the primary cause of death in China, and recurrence of stroke remains a major public health issue.
This cohort study is designed to evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of ischemic stroke in the patients with nonvalvular atrial fibrillation in China, compared with medicine approach (Warfarin or NOAC),.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- WATCHMAN transplantation, Oral anticoagulant drugs
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMAN transplantationDevice
WATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic
Oral anticoagulant drugsDrug
This group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ).For patients taking warfarin,international normalizedratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Followup visits occurred twice annually after the first year,with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected.
| Study group | Role | What they receive |
|---|---|---|
| WATCHMAN transplantation | This group will receive WATCHMAN device implantation.Device implantation included concomitant antithrombotic medication to facilitate device endothelialization: warfarin and aspirin for 45 days. To assess for device stability, peridevice leaks, and device-related thrombus, transesophageal echo (TEE) imaging was performed at 45 days, 6 months, and 12 months. When the 45-day TEE revealed minimal residual peridevice flow (jet width ≤5 mm) and no device-related thrombus, warfarin will be stopped and replaced by clopidogrel, 75 mg daily, until the 6-month visit, after which only aspirin was continued. If an adequate seal is not obtained or a thrombus is detected, patients continue taking warfarin until an adequate seal is attained or thrombus is resolved before transitioning to aspirin. Receives: Device: WATCHMAN transplantation | |
| Oral anticoagulant therapy | This group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ).
For patients taking warfarin, international normalized ratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Follow-up visits occurred twice annually after the first year, with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected. Receives: Drug: Oral anticoagulant drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
All stroke (including ischemic and hemorrhagic) and systemic embolism, cardiovascular death (limited to any cardiovascular and unexplained)
Measured: 3 years
Secondary outcomes (2)
All the serious complications,including the surgery complications and major bleeding events.
Measured: 3 years
All-cause death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start5 Nov 2017 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian-an Wang, MD,PhD, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327350
- Sponsor's protocol ID
- SAHZJU CT009
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WASPS Trails:WATCHMAN for Second Prevention of Stroke
- ClinicalTrials.gov ID
- NCT03327350
- Acronym / sponsor ID
- SAHZJU CT009
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 Nov 2017 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 31 Oct 2017 (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.
To evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of stroke in the patients with nonvalvular atrial fibrillation
Detailed description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting an estimated 5 million Chinese. Atrial fibrillation is the primary cardiac abnormality associated with embolic stroke; among patients with AF, there is an annual stroke rate, about 5 times for the same age population in sinus rhythm.
Although warfarin therapy is effective at reducing the risk of stroke, chronic anticoagulation presents problems of safety and acceptability for many patients. Drug and dietary interactions, frequent blood tests, and compliance issues all contribute to difficulties with chronic warfarin therapy. New oral anticoagulant compounds with better therapeutic range and without need for similar monitoring, such as Dabigatran, Rivaroxaban, Apixaban and Edoxaban,have been studied, but there is no direct comparison with left atrial appendage closure(LAAC).
However,the left atrial appendage (LAA) is the major location of thrombi in patients with AF. In patients with nonrheumatic AF and thrombus in the left atrium, the clot was located in the LAA in 90%. And the WATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic thromboembolism in patients with AF.The PROTECT-Af and PREVAIL trails confirmed this device's efficacy and safety, compared with warfarin, for preventing the combined outcome of stroke,systemic embolism, and cardiovascular death. And the device has been approved by China's FDA.
Stroke is the primary cause of death in China, and recurrence of stroke remains a major public health issue.
This cohort study is designed to evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of ischemic stroke in the patients with nonvalvular atrial fibrillation in China, compared with medicine approach (Warfarin or NOAC),.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WATCHMAN transplantation | – | Device: WATCHMAN transplantationThis group will receive WATCHMAN device implantation.Device implantation included concomitant antithrombotic medication to facilitate device endothelialization: warfarin and aspirin for 45 days. To assess for device stability, peridevice leaks, and device-related thrombus, transesophageal echo (TEE) imaging was performed at 45 days, 6 months, and 12 months. When the 45-day TEE revealed minimal residual peridevice flow (jet width ≤5 mm) and no device-related thrombus, warfarin will be stopped and replaced by clopidogrel, 75 mg daily, until the 6-month visit, after which only aspirin was continued. If an adequate seal is not obtained or a thrombus is detected, patients continue taking warfarin until an adequate seal is attained or thrombus is resolved before transitioning to aspirin. |
| Oral anticoagulant therapy | – | Drug: Oral anticoagulant drugsThis group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ). For patients taking warfarin, international normalized ratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Follow-up visits occurred twice annually after the first year, with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 hospitalized patients over 18 years old with nonvalvular atrial fibrillation will be enrolled consecutively
Key inclusion criteria (5 listed)
- Age 18 years or older;
- A history of stroke/transient ischemic attack(TIA) over 3 months;
- Paroxysmal, persistent, or permanent nonvalvular AF;
- 4.2 or more CHA2DS2-VASc risk factors
- Eligibility for long-term anticoagulation with warfarin or new oral anticoagulants.
Key exclusion criteria (6 listed)
- patent foramen ovale with atrial septal aneurysm
- an atrial septal defect
- mechanical valve prosthesis
- left ventricular ejection fraction less than 30%
- mobile aortic atheromata
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 transplantationWATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic | Device | WATCHMAN transplantation |
| Oral anticoagulant drugsThis group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ).For patients taking warfarin,international normalizedratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Followup visits occurred twice annually after the first year,with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected. | Drug | Oral anticoagulant therapy |
Primary outcome
All stroke (including ischemic and hemorrhagic) and systemic embolism, cardiovascular death (limited to any cardiovascular and unexplained)
Time frame: 3 years
2 secondary outcomes
All the serious complications,including the surgery complications and major bleeding events.
Time frame: 3 years
All-cause death
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- 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.
Jian-an Wang, MD,PhD principal investigator
Second Affiliated Hospital of Zhejiang University School of Medicine
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 Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 6 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 31 Oct 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?
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?
All stroke (including ischemic and hemorrhagic) and systemic embolism, cardiovascular death (limited to any cardiovascular and unexplained) (time frame: 3 years). 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 31 Oct 2017.