Registry on WATCHMAN Outcomes in Real-Life Utilization
EWOLUTION
2 other identifiers
observational
1,025
13 countries
47
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2013
CompletedStudy Start
First participant enrolled
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2018
CompletedResults Posted
Study results publicly available
May 7, 2019
CompletedMay 7, 2019
May 1, 2018
2 years
October 24, 2013
February 16, 2017
May 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Interventions
Eligibility Criteria
Patients with non-valvular atrial fibrillation
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
OLV Ziekenhuis
Aalst, Belgium
Hospitaux du Haut Leveque
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
Related Publications (2)
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.
PMID: 39082730DERIVEDBoersma 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.
PMID: 30939908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lucas V.A. Boersma
- Organization
- St. Antonius Ziekenhuis, Nieuwegein, Netherlands
Study Officials
- PRINCIPAL INVESTIGATOR
Lucas VA Boersma
St. Antonius Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2013
First Posted
October 30, 2013
Study Start
October 28, 2013
Primary Completion
November 1, 2015
Study Completion
January 4, 2018
Last Updated
May 7, 2019
Results First Posted
May 7, 2019
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share