Vanderbilt Clinical Trials

HEAL-LAA Clinical Trial

Purpose

The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.

Conditions

Atrial Fibrillation
Bleeding
Stroke

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Subject is of legal age to participate in the study. - Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve). - Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device. - Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study. - Subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria

Subject has a documented life expectancy of less than 6 months. - Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment. - 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. - The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated. - Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. - There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. - Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other Device Group	WATCHMAN FLX Pro LAAC Device Implantation	Device: WATCHMAN FLX Pro LAAC Device Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device Other names: Left Atrial Appendage Closure

More Details

Status: Active, not recruiting
Sponsor: Boston Scientific Corporation

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.