| NCT ID | NCT07262255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Non-valvular Atrial Fibrillation (AF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-12-17 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device. 2. 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). 3. Subject or legal representative who are willing and capable of providing informed consent. 4. Subject is able and willing to return for required follow-up visits and examinations. 5. 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: 1. Subject has a documented life expectancy of less than 12 months. 2. 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. 3. Intracardiac thrombus is present. 4. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. 5. The LAA anatomy will not accommodate a Closure Device. 6. Subject has a known hypersensitivity or contraindications according to IFU. 7. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
Contact & Investigator
Marek Grygier, Prof. MD, PHD
PRINCIPAL INVESTIGATOR
Uniwersytecki Szpital Kliniczny w Poznaniu
Frequently Asked Questions
Who can join the NCT07262255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-valvular Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07262255 currently recruiting?
Yes, NCT07262255 is actively recruiting participants. Contact the research team at Thomas.Naeschen@bsci.com for enrollment information.
Where is the NCT07262255 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Copenhagen, Denmark, Bad Oeynhausen, Germany, Berlin, Germany and 11 additional locations.
Who is sponsoring the NCT07262255 clinical trial?
NCT07262255 is sponsored by Boston Scientific Corporation. The principal investigator is Marek Grygier, Prof. MD, PHD at Uniwersytecki Szpital Kliniczny w Poznaniu. The trial plans to enroll 1,000 participants.
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