Atrial FibrillationPhase 4NCT02549963
Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban
A Phase 4 study testing WATCHMAN Left Atrial Appendage Occlusion Device and Rivaroxaban in people with Atrial Fibrillation and Stroke, run by Shulin Wu at 9 sites in China.
Trial summary
This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular 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 Left Atrial Appendage Occlusion Device and Rivaroxaban
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesChina
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 4
- 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
Who may be able to join
- Paroxysmal, persistent or permanent non-valvular atrial fibrillation
- Eligible for LAAO and long-term rivaroxaban therapy
- Calculated CHA2DS2-VASc score of 2 or greater.
Who cannot join
- Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants.
- Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment.
- History of atrial septal repair or has an atrial septal defect/patent foramen ovale device.
- History of valvular heart disease.
- Implanted mechanical valve prosthesis.
- New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 30%.
Show all 9Show fewer
- Patient has left atrial/left atrial appendage thrombus screened by echocardiography
- Platelet<100*109/L or hemoglobin<100g/L
- Expected lifespan less than 1 years
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Changsheng Ma, M.D. Ph.D.
Nanfang Hospital
Guangzhou, Guangdong, 510000
Xiaobo Huang, M.D. Ph.D.
The first Affiliated Hospital of Guangzhou medical University
Guangzhou, Guangdong, 510000
Wei Wang, M.D.
The first affiliated hospital of Jinan university
Guangzhou, Guangdong, 510000
Aidong Zhang, M.D. Ph.D.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yugang Dong, M.D. Ph.D.
The second Affiliated Hospital of Guangzhou medical University
Guangzhou, Guangdong, 510000
Shiming Liu, M.D. Ph.D.
Guangdong Cardiovascular Institute, Guangdong General Hospital
Guangzhou, Guangdong, 510080
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430000
Su Xi, M.D. Ph.D.
The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, 524000
Chan Chen, M.D. Ph.D.
About this study
Official title: A Prospective, Multi-Center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device With Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation
This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- WATCHMAN Left Atrial Appendage Occlusion Device, Rivaroxaban
- 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 Left Atrial Appendage Occlusion DeviceDevice
Also called WATCHMAN Left Atrial Appendage Closure
RivaroxabanDrug
Also called Novel Oral Anticoagulant
| Study group | Role | What they receive |
|---|---|---|
| WATCHMAN LAA Occlusion Device | Experimental | Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device. Receives: Device: WATCHMAN Left Atrial Appendage Occlusion Device |
| Rivaroxaban | Active comparator | Subjects assigned to receive the Rivaroxaban therapy. Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint
All Stroke or Systemic embolism or Cardiovascular death
Measured: 2 year
Secondary outcomes (4)
All bleeding event
Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.
Measured: 2 year
Major bleeding event
An overt bleeding accompanied by one or more of the following: a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding
Measured: 2 year
Technical and procedure related event
A pericardial effusion with a need for drainage, surgical or pericardiocentesis, or cardioembolic event during the procedure, or significant periprocedural bleeding (i.e. major vascular bleeding with a need for surgical revision, or blood concentrate transfusion), or device embolization, or thrombus of the device with a consequent cardioembolic event.
Measured: 45 days
Cognitive function change
Montreal Cognitive Assessment(MoCA) will be performed to detect cognitive function change.The differences between the MoCA test score in WATCHMAN group and in a control group of Rivaroxaban
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shulin Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital, Beijing Anzhen Hospital, First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Medical College, First Affiliated Hospital of Jinan University, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor-investigator, Shulin Wu, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549963
- Sponsor's protocol ID
- GDCI 201501
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
PubMed 25399274Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.
PubMed 24998121Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
PubMed 21830957
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device With Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02549963
- Acronym / sponsor ID
- GDCI 201501
- Conditions
- Atrial Fibrillation, Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shulin WuUniversity, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital, Beijing Anzhen Hospital, First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Medical College, First Affiliated Hospital of Jinan University, Nanfang Hospital, Southern Medical University
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- First posted
- 15 Sep 2015 (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 is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WATCHMAN LAA Occlusion Device | Experimental | Device: WATCHMAN Left Atrial Appendage Occlusion DeviceSubjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device. |
| Rivaroxaban | Active comparator | Drug: RivaroxabanSubjects assigned to receive the Rivaroxaban therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Paroxysmal, persistent or permanent non-valvular atrial fibrillation
- Eligible for LAAO and long-term rivaroxaban therapy
- Calculated CHA2DS2-VASc score of 2 or greater.
Key exclusion criteria (9 listed)
- Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants.
- Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment.
- History of atrial septal repair or has an atrial septal defect/patent foramen ovale device.
- History of valvular heart disease.
- Implanted mechanical valve prosthesis.
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 Left Atrial Appendage Occlusion DeviceAlso: WATCHMAN Left Atrial Appendage Closure | Device | WATCHMAN LAA Occlusion Device |
| RivaroxabanAlso: Novel Oral Anticoagulant | Drug | Rivaroxaban |
Primary outcome
Combined endpoint
Time frame: 2 year
All Stroke or Systemic embolism or Cardiovascular death
4 secondary outcomes
All bleeding event
Time frame: 2 year
Major bleeding event
Time frame: 2 year
Technical and procedure related event
Time frame: 45 days
Cognitive function change
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Background: PubMed 25399274Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
- Background: PubMed 24998121Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.
- Background: PubMed 21830957Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing WATCHMAN Left Atrial Appendage Occlusion Device and Rivaroxaban in people with Atrial Fibrillation and Stroke, run by Shulin Wu at 9 sites 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 9 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 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shulin Wu, M.D. Ph.D. (+8613902255336, doctorwushulin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint (time frame: 2 year). 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 NCT02549963, which also lists 3 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 24 Sep 2015.