Atrial Fibrillation Clinical Trials

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WATCHMAN FLX Pro European Registry

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital de Leon
RECRUITING
León
Clinica Universidad de Navarra
RECRUITING
Pamplona
Contact Information
Primary
Thomas Näschen, PhD
Thomas.Naeschen@bsci.com
+491707828594
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2028-09
Participants
Target number of participants: 1000
Treatments
Other: WATCHMAN FLX Pro
This arm is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device.~Approximately 300 patients undergo the LAAC procedure in conjunction with the use of the VersaCross Connect™ LAAC Access Solution.
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov