Registry on WATCHMAN Outcomes in Real-Life Utilization

Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke Clinical Trial

— EWOLUTION  

Official title:

Registry on WATCHMAN Outcomes in Real-Life Utilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972282
• Other study ID #: EWOLUTION
• Secondary ID: 90875647
• Status: Completed
• Start date: October 28, 2013
• Est. completion date: January 4, 2018

Study information

• Verified date: May 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1025
• Est. completion date: January 4, 2018
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
• Thromboembolism
• Thrombosis

Intervention

Device:
• WATCHMAN Left Atrial Appendage Closure

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
France	Hospitaux du Haut Leveque	Bordeaux
France	CHU Henri Mondor	Creteil
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
Germany	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	Duesseldorf
Germany	Elisabeth Krankenhaus	Essen
Germany	Cardio Vasculares Centrum Sankt Katharinen	Frankfurt
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt
Germany	Univeritatsmedizin Greifswald	Greifswald
Germany	Aklepios Klinik St Georg	Hamburg
Germany	Cardiologicum Hamburg	Hamburg
Germany	Universitatklinikum Leipzig	Leipzig
Germany	Universitatsmedizin Mainz	Mainz
Germany	Stadtisches Klinikum Neuperlach	Munich
Germany	Krankenhaus Barmherzige Bruder	Regensburg
Germany	Asklepios Klinik Weissenfels	Weissenfels
Ireland	Beaumont Hospital	Dublin
Italy	Ospedale Ferrarotto Alessi	Catania
Italy	ASL TO 4 Ospedale di Cirie	Cirie
Italy	Ospedale San Raffaele	Milan
Italy	Ospedale Sacro Cuore "Don Calabria"	Negrar
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Erasmus Medisch Centrum Rotterdam	Rotterdam
Poland	Szpital Uniwersytecki nr 1im dr A Jurasza	Bydgoszcz
Poland	Clinical Hospital University of Medicine	Poznan
Portugal	Hospital de Santa Maria	Lisbon
Russian Federation	Regional Vascular Center	Krasnoyarsk
Russian Federation	State Cardiology Research Center	Moscow
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
Saudi Arabia	King Fahed Medical City - Prince Salman Cardiac Center	Riyadh
Spain	Hospital Clinico Universitario de Salamanca	Salamanca
United Arab Emirates	Al Qassimi Hospital	Sharjah
United Kingdom	Royal Victoria Hospita	Belfast
United Kingdom	Royal Brompton & Harefield NHS Trust	London
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Portugal,  Russian Federation,  Saudi Arabia,  Spain,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Complications	All device/procedure related Serious Adverse Events (with or without Major intervention)	7 days post-implant
Primary	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
Primary	Death	All cause mortality	2 year follow-up