WATCHMAN FLX Pro European Registry
Recruiting · NCT07262255 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boston Scientific Corporation
View the official record on ClinicalTrials.gov →Interventions studied
Left atrial appendage closure
What this trial is about
The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. In a subregistry with approximately 300 patients, it is intended to use the VersaCross Connect™ LAAC Access Solution.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device.
- Subject has non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) and is clinically indicated for a WATCHMAN FLX™ Pro LAAC device, per the Instructions for Use (IFU).
- Subject or legal representative who are willing and capable of providing informed consent.
- Subject is able and willing to return for required follow-up visits and examinations.
- Subject whose age is 18 years or above, or who is of legal age to give informed consent specific to state and national law.
Exclusion criteria
- Subject has a documented life expectancy of less than 12 months.
- Subject who is currently enrolled in another investigational study or registry except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
- Intracardiac thrombus is present.
- An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
- The LAA anatomy will not accommodate a Closure Device.
- Subject has a known hypersensitivity or contraindications according to IFU.
- Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
Where it is running
20 locations listed.
- Aarhus University Hospital - Aarhus, Denmark
- Herz-und Diabeteszentrum Nordrhein-Westfalen - Bad Oeynhausen, Germany
- University Hospital Basel - Basel, Switzerland
- Charite, Campus Benjamin Franklin - Berlin, Germany
- INSELSPITAL - Universitätsspital Bern - Bern, Switzerland
- Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco - Catania, Italy
- Rigshospitalet Copenhagen - Copenhagen, Denmark
- Kath Krankenhaus St Johann Nepomuk - Erfurt, Germany
- Asklepios Klinik Saint Georg - Hamburg, Germany
- Asklepios Klinik Nord Heidberg - Hamburg, Germany
- Asklepios Klinik Altona - Hamburg, Germany
- Hospital de Leon - León, Spain
- Universitaetsklinikum Schleswig-Holstein - Lübeck, Germany
- Centro Cardiologico Monzino - Milan, Italy
- Clinica Universidad de Navarra - Pamplona, Spain
- Complejo Hospitalario de Pontevedra - Pontevedra, Spain
- Complejo Hospitalario Universitario de Pontevedra - Pontevedra, Spain
- Uniwersytecki Szpital Kliniczny w Poznaniu - Poznan, Poland
- Hospital Clinico Salamanca - Salamanca, Spain
- Ospedale Sacro Cuore Don Calabria - Verona, Italy