Recruiting NCT07262255
WATCHMAN FLX Pro European Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Left atrial appendage closure.
- Who it may be relevant to
- Registry conditions: Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Germany, Italy, Poland, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Left atrial appendage closure
The WATCHMAN FLX Pro LAAC Technology is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in adult patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy. The VersaCross Connect™ LAAC Access Solution is indicated for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chamb
Primary outcome measures
- Number of participants with a safety event treated with the WATCHMAN FLX Pro [Time frame: Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later]
- Number of participants with a safety event treated with the VersaCross Connect™ LAAC Access Solution [Time frame: Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later]
- Number of participants with a successful VersaCross Connect™ LAAC Access Solution treatment [Time frame: Completion of transseptal puncture]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 7 centers
- Herz-und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen
- Charite, Campus Benjamin Franklin — Berlin
- Kath Krankenhaus St Johann Nepomuk — Erfurt
- Asklepios Klinik Saint Georg — Hamburg
- Asklepios Klinik Nord Heidberg — Hamburg
- Asklepios Klinik Altona — Hamburg
- Universitaetsklinikum Schleswig-Holstein — Lübeck
Spain · 4 centers
- Hospital de Leon — León
- Clinica Universidad de Navarra — Pamplona
- Complejo Hospitalario Universitario de Pontevedra — Pontevedra
- Hospital Clinico Salamanca — Salamanca
Denmark · 2 centers
- Aarhus University Hospital — Aarhus
- Rigshospitalet Copenhagen — Copenhagen
Italy · 2 centers
- Centro Cardiologico Monzino — Milan
- Ospedale Sacro Cuore Don Calabria — Verona
Switzerland · 2 centers
- University Hospital Basel — Basel
- INSELSPITAL - Universitätsspital Bern — Bern
Poland · 1 center
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
Identifiers
NCT: NCT07262255 · S2603