Non-valvular Atrial FibrillationNCT02654470
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)
An observational study of Non-valvular Atrial Fibrillation, run by Boston Scientific Corporation at 17 sites in 9 countries.
Trial summary
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- Watchman FLX
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 17 sitesin 9 countries
- Study dates
- 16 Jul 2019to 28 Sep 2021
- 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: All subjects who meet all inclusion and no exclusion criteria can be enrolled. A subject who signs informed consent is considered enrolled in the study. The subjects selected for participation will be from the investigator's general patient population.
Who may be able to join
- Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
- Subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
- Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Who cannot join
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the Subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility
- The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- Documented life expectancy of less than 12 months.
Trial locations and contacts
17 sites in 9 countries.
17 sites in 9 countries
Germany6 sites
Elisabeth Krankenhaus
Essen
Cardio Vasculares Centrum Sankt Katharinen
Frankfurt
Cardioangiologisches Centrum Bethanien
Frankfurt
Cardiologicum Hamburg
Hamburg, 22041
Uni Jena
Jena
Herzzentrum Universität Leipzig
Leipzig
Spain2 sites
Hospital De La Santa Creu I Sant Pau
Barcelona
Hospital Virgen Macarena
Seville
United Kingdom2 sites
Royal Sussex County Hospital
Brighton
John Radcliffe Hospital
Oxford
About this study
Official title: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
Read the detailed description
WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- Watchman FLX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watchman FLXDevice
Patients who are receiving the Watchman FLX device
What is being measured
The primary outcome is the main question the study is designed to answer.
procedural success
Measured: 7 days post-implant
incidence of stroke, leak, thrombus and death
Measured: 1 year
procedural complications
Measured: 7-days post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start16 Jul 2019
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Timothy Betts, Principal investigator, John Radcliffe Hospital, Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654470
- Sponsor's protocol ID
- FLXibility
- Status last verified
- Nov 2021
- First submitted
- 11 Jan 2016
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
- ClinicalTrials.gov ID
- NCT02654470
- Acronym / sponsor ID
- FLXibility
- Conditions
- Non-valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research, IQVIA Pty Ltd
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 13 Jan 2016 (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.
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
Detailed description
WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who meet all inclusion and no exclusion criteria can be enrolled. A subject who signs informed consent is considered enrolled in the study. The subjects selected for participation will be from the investigator's general patient population.
Key inclusion criteria (3 listed)
- Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
- Subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
- Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Key exclusion criteria (4 listed)
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the Subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility
- The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- Documented life expectancy of less than 12 months.
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 FLXPatients who are receiving the Watchman FLX device | Device | – |
Primary outcome
procedural success
Time frame: 7 days post-implant
incidence of stroke, leak, thrombus and death
Time frame: 1 year
procedural complications
Time frame: 7-days post implant
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 19 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Non-valvular Atrial Fibrillation
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WATCHMAN FLX Pro European Registry
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LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
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Recruiting
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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.
Timothy Betts principal investigator
John Radcliffe Hospital, Oxford, UK
17 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation, run by Boston Scientific Corporation at 17 sites in 9 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 3 inclusion and 4 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 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Italy, Spain, United Kingdom, Denmark and 4 more countries. 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?
procedural success (time frame: 7 days post-implant). The study lists 3 primary outcomes in all. 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 19 Nov 2021; AzTrials last refreshed its copy on 28 Oct 2026.