WATCHMAN FLX Pro European Registry

Boston Scientific Corporation1,000 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

1,000

Conditions

Non-valvular Atrial Fibrillation (AF)Left Atrial Appendage Closure

Interventions

Left atrial appendage closureDEVICE

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 chambers, including the left atrium via transseptal perforation / puncture.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hospital de Leon

León, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

RECRUITING

Outcomes

Primary Outcomes

Number of participants with a safety event treated with the WATCHMAN FLX Pro

Proportion of subjects with one or more of the following events between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and minor nonsurgical treatments of access site complications are excluded from this endpoint.

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

Proportion of subjects with one or more of the following events between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later: For all enrolled subjects, who had an attempt to insert the VersaCross Connect™ LAAC Access Solution device, the composite rate of all-cause death, all stroke, systemic embolism, pericardial effusion resulting in interventions\*, and ISTH major bleeding. \*Pericardial effusion/tamponade requiring pericardiocentesis or surgery to treat

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

VersaCross Connect™ LAAC Access Solution acute procedural success: Acute Procedural Success is defined as transseptal puncture success (VersaCross RF-wire crossing into left atrium).

Time frame: Completion of transseptal puncture

Central Contacts

Thomas Näschen, PhD

CONTACT

+491707828594 Thomas.Naeschen@bsci.com

Data from ClinicalTrials.gov

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