Brief Summary
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.
Brief Title
HEAL-LAA Clinical Trial
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Atrial Fibrillation
Bleeding
Stroke
Eligibility Criteria
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).
* 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).
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05809596
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
s2504
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
Primary Outcomes
Outcome Description
Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.
Outcome Measure
The rate of leak (>5 mm) for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than the rate of leak (> 5mm) of the performance goal.
Outcome Time Frame
45 days
Outcome Description
Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.
Outcome Measure
The composite rate of all-cause mortality, all stroke, systemic embolism, and major bleeding for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than a performance goal.
Outcome Time Frame
6 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637