Atrial FibrillationASAPNCT00851578
ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
A study testing WATCHMAN in people with Atrial Fibrillation, run by Boston Scientific Corporation at 4 sites in 2 countries.
Trial summary
The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- WATCHMAN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2009to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- paroxysma, persistent, or permanent non-vlavular atrial fibrillation
- contraindicated to warfarin
- eligible for clopidogrel, ticlopdine, heparin, or aspirin
- CHADS score 1 or greater
Who cannot join
- NYHA Class IV
- LAA obliteration
- Heart transplant
- LVEF less than 30%
- greater than 50% carotid stenosis
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Sankt Katharinen Hospital / Cardiovasculares Centrum
Frankfurt, 60389
Herzzentrum Leipzig
Leipzig, 04289
Chefarzt der Medizinischen Klinik III/Kardiologie
Regensburg, 93049
About this study
The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.
- Conditions
- Atrial Fibrillation
- Being tested
- WATCHMAN
- Keywords
- AF, atrial fibrillation, LAA occlusion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMANDevice
WATCHMAN LAA Closure Device
| Study group | Role | What they receive |
|---|---|---|
| WATCHMAN | Experimental | non-valvular atrial fibrillation patients contraindicated to warfarin Receives: Device: WATCHMAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851578
- Sponsor's protocol ID
- ST1056
- Acronym
- ASAP
- Status last verified
- Sep 2013
- First submitted
- 24 Feb 2009
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.
PubMed 23583249
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
- ClinicalTrials.gov ID
- NCT00851578
- Acronym / sponsor ID
- ASAP / ST1056
- Conditions
- Atrial Fibrillation
- Keywords
- AF, atrial fibrillation, LAA occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2009 (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.
The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WATCHMAN | Experimental | Device: WATCHMANnon-valvular atrial fibrillation patients contraindicated to warfarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- paroxysma, persistent, or permanent non-vlavular atrial fibrillation
- contraindicated to warfarin
- eligible for clopidogrel, ticlopdine, heparin, or aspirin
- CHADS score 1 or greater
Key exclusion criteria (5 listed)
- NYHA Class IV
- LAA obliteration
- Heart transplant
- LVEF less than 30%
- greater than 50% carotid stenosis
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 |
|---|---|---|
| WATCHMANWATCHMAN LAA Closure Device | Device | WATCHMAN |
Primary outcome
Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Derived from this study: PubMed 23583249Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 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.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATCHMAN in people with Atrial Fibrillation, run by Boston Scientific Corporation at 4 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment (time frame: 2 years). 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 NCT00851578, which also lists 1 linked publication.
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 27 Jan 2015.