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| ID | Type | Description | Link |
|---|---|---|---|
| 90875647 | Other Identifier | Boston Scientific |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN Left Atrial Appendage Closure | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Complications | All device/procedure related Serious Adverse Events (with or without Major intervention) | 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 | 2 year follow-up |
| Death | All cause mortality | 2 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-valvular atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Lucas VA Boersma | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Ziekenhuis | Aalst | Belgium | ||||
| Hospitaux du Haut Leveque |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39082730 | Derived | 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. | |
| 30939908 |
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5 patients signed the informed consent but never underwent the implant procedures. Those patients are classified as intents, they are included in epidemiological baseline analyses, but not on the endpoint analysis. 1020 patients underwent the implant procedure and are included in all endpoint analyses, regardless of the success of the implant.
1025 patients scheduled for a WATCHMAN implant at 47 centers in 13 countries were enrolled over a time period of 19 months prior to the start of the procedure (Oct 2013 - May 2015)
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| ID | Title | Description |
|---|---|---|
| FG000 | WATCHMAN | Patients who are implanted with the WATCHMAN device in a commercial clinical setting. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2014 |
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| Bordeaux |
| France |
| CHU Henri Mondor | Créteil | France |
| University Hospital | Grenoble | France |
| CHRU Lille | Lille | France |
| CHU La Timone Hospital | Marseille | France |
| Nouvelles Cliniques Nantaises | Nantes | France |
| Groupe hospitalier Bichat Claude Bernard | Paris | France |
| Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie | Berlin | Germany |
| Vivantes Klinikum Am Urban | Berlin | Germany |
| Vivantes Klinikum im Friedrichshain | Berlin | Germany |
| Evangelisches Krankenhaus | Bielefeld | Germany |
| Universitatklinikum Medizinische | Bonn | Germany |
| Dominikus-Krankenhaus | Düsseldorf | Germany |
| Elisabeth Krankenhaus | Essen | Germany |
| Cardio Vasculares Centrum Sankt Katharinen | Frankfurt | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt | Germany |
| Univeritatsmedizin Greifswald | Greifswald | Germany |
| Cardiologicum Hamburg | Hamburg | 22041 | Germany |
| Aklepios Klinik St Georg | Hamburg | Germany |
| Universitatklinikum Leipzig | Leipzig | Germany |
| Universitatsmedizin Mainz | Mainz | Germany |
| Stadtisches Klinikum Neuperlach | Munich | Germany |
| Krankenhaus Barmherzige Bruder | Regensburg | Germany |
| Asklepios Klinik Weissenfels | Weißenfels | Germany |
| Beaumont Hospital | Dublin | Ireland |
| Ospedale Ferrarotto Alessi | Catania | Italy |
| ASL TO 4 Ospedale di Cirie | Cirié | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Ospedale Sacro Cuore "Don Calabria" | Negrar | Italy |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| Erasmus Medisch Centrum Rotterdam | Rotterdam | Netherlands |
| Szpital Uniwersytecki nr 1im dr A Jurasza | Bydgoszcz | Poland |
| Clinical Hospital University of Medicine | Poznan | Poland |
| Hospital de Santa Maria | Lisbon | Portugal |
| Regional Vascular Center | Krasnoyarsk | Russia |
| State Cardiology Research Center | Moscow | Russia |
| State Research Institute of Circulation Pathology | Novosibirsk | Russia |
| King Fahed Medical City - Prince Salman Cardiac Center | Riyadh | Saudi Arabia |
| Hospital Clinico Universitario de Salamanca | Salamanca | Spain |
| Al Qassimi Hospital | Sharjah city | United Arab Emirates |
| Royal Victoria Hospita | Belfast | United Kingdom |
| Royal Brompton & Harefield NHS Trust | London | United Kingdom |
| Freeman Hospital | Newcastle | United Kingdom |
| John Radcliffe Hospital | Oxford | United Kingdom |
| Derived |
| Boersma 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. |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled patients are included in Baseline analyses including 5 patients who never underwent the study procedure
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| ID | Title | Description |
|---|---|---|
| BG000 | WATCHMAN | Patients who are implanted with the WATCHMAN device in a commercial clinical setting. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| CHADS-VASc | Total score used to determine adjusted stroke rate, based on the number of risk factors presented by a patient. The higher the number of risk factors, the higher the risk of stroke. Range of score: 0 (lower risk) - 9 (higher risk). CHA2DS2-VASc = Congestive heart failure (1 point), Hypertension (1 point), Age ≥75 years (2 points), Diabetes (1 point), Prior Stroke or TIA or thromboembolism (2 points), Vascular disease (1 point), Age 65-74 years (1 point), Sex category (female) (1 point). | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||||
| HAS-BLED | Score To Assess 1-Year Risk of Major Bleeding in Patients With Atrial Fibrillation, based on the number of risk factors presented by a patient. The higher the number of risk factors, the higher the risk of major bleeding. Range of score: 0 (lower risk) - 9 (higher risk). HAS-BLED = Hypertension, Abnormal Renal function, Abnormal Liver function, Stroke, Bleeding, Labile INR, Elderly: Age >65, Concomitant use of Drugs, Alcohol abuse (1 point each) | Mean | Standard Deviation | scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedural Complications | All device/procedure related Serious Adverse Events (with or without Major intervention) | Posted | Number | percentage of participants | 7 days post-implant |
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| Primary | Ischemic Stroke | occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU | Patients who undergo WATCHMAN implant procedure in a commercial clinical setting | Posted | Number | 95% Confidence Interval | Nr events/100 Patient-years | 2 year follow-up |
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| Primary | Death | All cause mortality | Patients who undergo WATCHMAN implant in a commercial clinical setting. | Posted | Count of Participants | Participants | 2 year follow-up |
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2 years
Overall number of participants who died due to any cause
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WATCHMAN | Patients who are implanted with the WATCHMAN device in a commercial clinical setting. | 161 | 1,020 | 26 | 1,020 | 0 | 1,020 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Device/Procedure related Serious Adverse Events | Cardiac disorders | Systematic Assessment | Bleeding; Hematoma; groin vascular damage; device embolization; incomplete seal at device release; pericardial effusion/tamponade; respiratory insufficiency; coronary air embolism; cerebral air embolism; hypotension; adverse reaction to anaesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucas V.A. Boersma | St. Antonius Ziekenhuis, Nieuwegein, Netherlands | l.boersma@antoniusziekenhuis.nl |
| Jan 8, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| United Arab Emirates |
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| Portugal |
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| Spain |
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| Saudi Arabia |
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| Netherlands |
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| Belgium |
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| Ireland |
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| Poland |
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| Italy |
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| France |
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| Germany |
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