Registry on WATCHMAN Outcomes in Real-Life Utilization
- Conditions
- Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
- Registration Number
- NCT01972282
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1025
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural Complications 7 days post-implant All device/procedure related Serious Adverse Events (with or without Major intervention)
Ischemic Stroke 2 year follow-up occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU
Death 2 year follow-up All cause mortality
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
CHRU Lille
🇫🇷Lille, France
Cardio Vasculares Centrum Sankt Katharinen
🇩🇪Frankfurt, Germany
Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt, Germany
University Hospital
🇫🇷Grenoble, France
Evangelisches Krankenhaus
🇩🇪Bielefeld, Germany
ASL TO 4 Ospedale di Cirie
🇮🇹Cirie, Italy
Szpital Uniwersytecki nr 1im dr A Jurasza
🇵🇱Bydgoszcz, Poland
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
CHU Henri Mondor
🇫🇷Creteil, France
Dominikus-Krankenhaus
🇩🇪Duesseldorf, Germany
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie
🇩🇪Berlin, Germany
OLV Ziekenhuis
🇧🇪Aalst, Belgium
Hospitaux du Haut Leveque
🇫🇷Bordeaux, France
CHU La Timone Hospital
🇫🇷Marseille, France
Groupe hospitalier Bichat Claude Bernard
🇫🇷Paris, France
Universitatklinikum Medizinische
🇩🇪Bonn, Germany
Elisabeth Krankenhaus
🇩🇪Essen, Germany
Univeritatsmedizin Greifswald
🇩🇪Greifswald, Germany
Cardiologicum Hamburg
🇩🇪Hamburg, 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
Ospedale Ferrarotto Alessi
🇮🇹Catania, Italy
Beaumont Hospital
🇮🇪Dublin, Ireland
Ospedale San Raffaele
🇮🇹Milan, Italy
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Ospedale Sacro Cuore "Don Calabria"
🇮🇹Negrar, Italy
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Erasmus Medisch Centrum Rotterdam
🇳🇱Rotterdam, Netherlands
Clinical Hospital University of Medicine
🇵🇱Poznan, Poland
Hospital de Santa Maria
🇵🇹Lisbon, Portugal
Regional Vascular Center
🇷🇺Krasnoyarsk, Russian Federation
State Cardiology Research Center
🇷🇺Moscow, Russian Federation
State Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
King Fahed Medical City - Prince Salman Cardiac Center
🇸🇦Riyadh, Saudi Arabia
Royal Victoria Hospita
🇬🇧Belfast, United Kingdom
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Al Qassimi Hospital
🇦🇪Sharjah, United Arab Emirates
Royal Brompton & Harefield NHS Trust
🇬🇧London, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom