For Healthcare Professionals

HEAL-LAA Clinical Trial

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Subject is of legal age to participate in the study.
  2. 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).
  3. Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.
  4. Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
  5. Subject is able and willing to return for required follow-up visits and examinations.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Subject has a documented life expectancy of less than 6 months.
  2. 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.
  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. 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.
  7. 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.
  8. There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.
  9. 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).
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-800-CARDIACEmail iconEmail Study Center

Study Details


Contition

Atrial Fibrillation,Bleeding,Stroke

Age

18+

Phase

NA

Participants Needed

1000

Est. Completion Date

Jun 30, 2025

Treatment Type

INTERVENTIONAL


Sponsor

Boston Scientific Corporation

ClinicalTrials.gov NCT Identifier

NCT05809596

Study Number

S2504

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