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 |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Boston Scientific Corporation