Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, StrokeEWOLUTIONNCT01972282
Registry on WATCHMAN Outcomes in Real-Life Utilization
An observational study of Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke, run by Boston Scientific Corporation at 47 sites in 13 countries.
Trial summary
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
- What is being tested?
- WATCHMAN Left Atrial Appendage Closure
- Type of treatment
- Medical device
- How many people
- 1,025 participants
- Where
- 47 sitesin 13 countries
- Study dates
- 28 Oct 2013to 4 Jan 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with non-valvular atrial fibrillation
Who may be able to join
- Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion;
- Patient who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Who cannot join
- Patient who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient 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;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Trial locations and contacts
47 sites in 13 countries.
47 sites in 13 countries
Germany17 sites
Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie
Berlin
Vivantes Klinikum Am Urban
Berlin
Vivantes Klinikum im Friedrichshain
Berlin
Evangelisches Krankenhaus
Bielefeld
Universitatklinikum Medizinische
Bonn
Dominikus-Krankenhaus
Düsseldorf
Elisabeth Krankenhaus
Essen
Cardio Vasculares Centrum Sankt Katharinen
Frankfurt
Cardioangiologisches Centrum Bethanien
Frankfurt
Univeritatsmedizin Greifswald
Greifswald
Cardiologicum Hamburg
Hamburg, 22041
Aklepios Klinik St Georg
Hamburg
Universitatklinikum Leipzig
Leipzig
Universitatsmedizin Mainz
Mainz
Stadtisches Klinikum Neuperlach
Munich
Krankenhaus Barmherzige Bruder
Regensburg
Asklepios Klinik Weissenfels
Weißenfels
France7 sites
Hospitaux du Haut Leveque
Bordeaux
CHU Henri Mondor
Créteil
University Hospital
Grenoble
CHRU Lille
Lille
CHU La Timone Hospital
Marseille
Nouvelles Cliniques Nantaises
Nantes
Groupe hospitalier Bichat Claude Bernard
Paris
Italy4 sites
Ospedale Ferrarotto Alessi
Catania
ASL TO 4 Ospedale di Cirie
Cirié
Ospedale San Raffaele
Milan
Ospedale Sacro Cuore "Don Calabria"
Negrar
Netherlands4 sites
Medisch Spectrum Twente
Enschede
Medisch Centrum Leeuwarden
Leeuwarden
St. Antonius Hospital
Nieuwegein
Erasmus Medisch Centrum Rotterdam
Rotterdam
United Kingdom4 sites
Royal Victoria Hospita
Belfast
Royal Brompton & Harefield NHS Trust
London
Freeman Hospital
Newcastle
John Radcliffe Hospital
Oxford
Russia3 sites
Regional Vascular Center
Krasnoyarsk
State Cardiology Research Center
Moscow
State Research Institute of Circulation Pathology
Novosibirsk
Poland2 sites
Szpital Uniwersytecki nr 1im dr A Jurasza
Bydgoszcz
Clinical Hospital University of Medicine
Poznan
Saudi Arabia1 site
King Fahed Medical City - Prince Salman Cardiac Center
Riyadh
About this study
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.
Read the detailed description
Approximately 1000 subjects will be enrolled in the study. To reduce the impact of individual center bias, each site may include up to 45 subjects and each country may include a maximum of 500 patients. Up to 70 sites (international, outside of US) will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.
Each patient will be followed for a period of two years after enrollment according to the schedule and standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, then at one post-implant visit (typically between 1-3 months of implant), and then annually through 2 years post implant. An intermediate visit may be scheduled in a number of patients, per physician discretion. In order to reliably capture patient status at study end, a follow-up window of 24 +/- 3 months will be considered acceptable for scheduling the last visit.
For subjects who are not scheduled to visit the clinic for a follow-up, a subject contact (e.g. phone call) will ensure capture of the endpoint related information; however, it is recommended to perform an in-office visit for at least the first annual visit.
Enrollment is expected to be completed in 21 months; therefore, the total study duration is estimated to be 48 months.
- Being tested
- WATCHMAN Left Atrial Appendage Closure
- Keywords
- Atrial fibrillation, Stroke, Thrombus, Thromboembolism, Left atrial appendage
- Medical subject headings
- Thromboembolism, Stroke, Atrial Fibrillation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMAN Left Atrial Appendage ClosureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Complications
All device/procedure related Serious Adverse Events (with or without Major intervention)
Measured: 7 days post-implant
Ischemic Stroke
occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU
Measured: 2 year follow-up
Death
All cause mortality
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study start28 Oct 2013
- Primary completionNov 2015
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, StrokeStudies 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
- 1,025 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lucas VA Boersma, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972282
- Sponsor's protocol ID
- EWOLUTION
- Other IDs
- 90875647
- Acronym
- EWOLUTION
- Status last verified
- May 2018
- First submitted
- 24 Oct 2013
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aarnink EW, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW, Boersma LVA. Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial. Europace. 2024 Jul 2;26(7):euae188. doi: 10.1093/europace/euae188.
PubMed 39082730Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Foley D, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW; following investigators and institutions participated in the EWOLUTION study. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006841. doi: 10.1161/CIRCEP.118.006841.
PubMed 30939908
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry on WATCHMAN Outcomes in Real-Life Utilization
- ClinicalTrials.gov ID
- NCT01972282
- Acronym / sponsor ID
- EWOLUTION / EWOLUTION
- Keywords
- Atrial fibrillation, Stroke, Thrombus, Thromboembolism, Left atrial appendage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.
Detailed description
Approximately 1000 subjects will be enrolled in the study. To reduce the impact of individual center bias, each site may include up to 45 subjects and each country may include a maximum of 500 patients. Up to 70 sites (international, outside of US) will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.
Each patient will be followed for a period of two years after enrollment according to the schedule and standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, then at one post-implant visit (typically between 1-3 months of implant), and then annually through 2 years post implant. An intermediate visit may be scheduled in a number of patients, per physician discretion. In order to reliably capture patient status at study end, a follow-up window of 24 +/- 3 months will be considered acceptable for scheduling the last visit.
For subjects who are not scheduled to visit the clinic for a follow-up, a subject contact (e.g. phone call) will ensure capture of the endpoint related information; however, it is recommended to perform an in-office visit for at least the first annual visit.
Enrollment is expected to be completed in 21 months; therefore, the total study duration is estimated to be 48 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular atrial fibrillation
Key inclusion criteria (3 listed)
- Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion;
- Patient who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Key exclusion criteria (3 listed)
- Patient who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient 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;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
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 Closure | Device | – |
Primary outcome
Procedural Complications
Time frame: 7 days post-implant
All device/procedure related Serious Adverse Events (with or without Major intervention)
Ischemic Stroke
Time frame: 2 year follow-up
occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU
Death
Time frame: 2 year follow-up
All cause mortality
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39082730Aarnink EW, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW, Boersma LVA. Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial. Europace. 2024 Jul 2;26(7):euae188. doi: 10.1093/europace/euae188.
- Derived from this study: PubMed 30939908Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Foley D, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW; following investigators and institutions participated in the EWOLUTION study. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006841. doi: 10.1161/CIRCEP.118.006841.
- Individual participant dataSharing planned: No
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.
Lucas VA Boersma principal investigator
St. Antonius Hospital
47 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke, run by Boston Scientific Corporation at 47 sites in 13 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 3 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany, France, Italy, Netherlands, United Kingdom and 8 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?
Yes. Results are posted in the registry (first posted 7 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Complications (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?
On the ClinicalTrials.gov record for NCT01972282, which also lists 2 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 7 May 2019.