Registry on WATCHMAN Outcomes in Real-Life Utilization (EWOLUTION)

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.

Study Overview

• Status: Completed
• Conditions: Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
• Intervention / Treatment: Device: WATCHMAN Left Atrial Appendage Closure

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 Type: Observational
• Enrollment (Actual): 1025

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV Ziekenhuis
• France
  • Bordeaux, France
    • Hospitaux du Haut Leveque
  • Creteil, France
    • Chu Henri Mondor
  • Grenoble, France
    • University Hospital
  • Lille, France
    • CHRU Lille
  • Marseille, France
    • CHU La Timone Hospital
  • Nantes, France
    • Nouvelles Cliniques Nantaises
  • Paris, France
    • Groupe Hospitalier Bichat Claude Bernard
• Germany
  • Berlin, Germany
    • Vivantes Klinikum Am Urban
  • Berlin, Germany
    • Vivantes Klinikum im Friedrichshain
  • Berlin, Germany
    • Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie
  • Bielefeld, Germany
    • Evangelisches Krankenhaus
  • Bonn, Germany
    • Universitatklinikum Medizinische
  • Duesseldorf, Germany
    • Dominikus-Krankenhaus
  • Essen, Germany
    • Elisabeth Krankenhaus
  • Frankfurt, Germany
    • Cardioangiologisches Centrum Bethanien
  • Frankfurt, Germany
    • Cardio Vasculares Centrum Sankt Katharinen
  • Greifswald, Germany
    • Univeritatsmedizin Greifswald
  • Hamburg, Germany, 22041
    • Cardiologicum Hamburg
  • Hamburg, Germany
    • Aklepios Klinik St Georg
  • Leipzig, Germany
    • Universitätklinikum Leipzig
  • Mainz, Germany
    • Universitätsmedizin Mainz
  • Munich, Germany
    • Städtisches Klinikum Neuperlach
  • Regensburg, Germany
    • Krankenhaus Barmherzige Brüder
  • Weissenfels, Germany
    • Asklepios Klinik Weissenfels
• Ireland
  • Dublin, Ireland
    • Beaumont Hospital
• Italy
  • Catania, Italy
    • Ospedale Ferrarotto Alessi
  • Cirie, Italy
    • ASL TO 4 Ospedale di Cirie
  • Milan, Italy
    • Ospedale San Raffaele
  • Negrar, Italy
    • Ospedale Sacro Cuore "Don Calabria"
• Netherlands
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
  • Rotterdam, Netherlands
    • Erasmus Medisch Centrum Rotterdam
• Poland
  • Bydgoszcz, Poland
    • Szpital Uniwersytecki nr 1im dr A Jurasza
  • Poznan, Poland
    • Clinical Hospital University of Medicine
• Portugal
  • Lisbon, Portugal
    • Hospital de Santa Maria
• Russian Federation
  • Krasnoyarsk, Russian Federation
    • Regional Vascular Center
  • Moscow, Russian Federation
    • State Cardiology Research Center
  • Novosibirsk, Russian Federation
    • State Research Institute of Circulation Pathology
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Fahed Medical City - Prince Salman Cardiac Center
• Spain
  • Salamanca, Spain
    • Hospital Clinico Universitario de Salamanca
• United Arab Emirates
  • Sharjah, United Arab Emirates
    • Al Qassimi Hospital
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospita
  • London, United Kingdom
    • Royal Brompton & Harefield NHS Trust
  • Newcastle, United Kingdom
    • Freeman Hospital
  • Oxford, United Kingdom
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular atrial fibrillation

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Lucas VA Boersma, St. Antonius Ziekenhuis Nieuwegein, The Netherlands

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): January 4, 2018

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 30, 2013

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Stroke; Atrial fibrillation; Thrombus; Left atrial appendage; Thromboembolism
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thrombosis; Thromboembolism
• Other Study ID Numbers: EWOLUTION; 90875647 (Other Identifier: Boston Scientific)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No