Atrial FibrillationHEAL-LAANCT05809596

HEAL-LAA Clinical Trial

A study testing WATCHMAN FLX Pro LAAC Device in people with Atrial Fibrillation and Bleeding, run by Boston Scientific Corporation at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation, Bleeding, Stroke
What is being tested?: WATCHMAN FLX Pro LAAC Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 949 participants
Where: 45 sitesUnited States
Study dates: 3 Oct 2023to 18 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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).

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

Emory University
Atlanta, Georgia, 30342
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
University of Alabama Medical Center
Birmingham, Alabama, 35233
Grandview Medical Center/ Affinity Cardiovascular Specialists
Birmingham, Alabama, 35243
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Manatee Memorial Hospital
Bradenton, Florida, 34205
Kaleida Health - Gates Vascular Institute
Buffalo, New York, 14203
Novant Health Heart & Vascular Institute
Charlotte, North Carolina, 28204
Sanger Heart and Vascular Institute-Carolinas Medical Center
Charlotte, North Carolina, 28204
Erlanger Health, Inc.,
Chattanooga, Tennessee, 37403
Cleveland Clinic
Cleveland, Ohio, 44195
UC Health Memorial Hospital Central
Colorado Springs, Colorado, 80909
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Corewell Health
Grand Rapids, Michigan, 49525
Straub Medical Center
Honolulu, Hawaii, 96813
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77094
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
University of Kansas Health System
Kansas City, Kansas, 66160
Saint Luke's Health System
Kansas City, Missouri, 64111
Scripps Memorial Hospital
La Jolla, California, 92307
Good Samaritan Hospital
Los Angeles, California, 90017
Virtua Health
Marlton, New Jersey, 08053
UPMC Pinnacle Health at Harrisburg Hospital
Mechanicsburg, Pennsylvania, 17050
Ascension Saint Thomas
Nashville, Tennessee, 37203
Centennial Medical Center
Nashville, Tennessee, 37203
Cardiology Associates of Fairfield County, P.C.
Norwalk, Connecticut, 06851
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
Eisenhower Medical Center
Rancho Mirage, California, 92270
Mayo Clinic
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York, 14621
St. Mark's Hospital
Salt Lake City, Utah, 84124
Methodist Hospital
San Antonio, Texas, 78229
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Memorial Health University Medical Center
Savannah, Georgia, 31404
Montefiore Medical Center
The Bronx, New York, 10467
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Tucson Medical Center
Tucson, Arizona, 85712
Christus Trinity Mother Frances
Tyler, Texas, 75701
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
WellSpan York Hospital
York, Pennsylvania, 17403

Other trials in United States

About this study

Official title: HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device

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
Being tested: WATCHMAN FLX Pro LAAC Device
Medical subject headings: Atrial Fibrillation, Hemorrhage, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WATCHMAN FLX Pro LAAC DeviceDevice
Also called Left Atrial Appendage Closure
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device

Study groups in NCT05809596
Study group	Role	What they receive
Device Group	Other	WATCHMAN FLX Pro LAAC Device Implantation Receives: Device: WATCHMAN FLX Pro LAAC Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
Incomplete seal with peri-device gap > 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
Measured: 45 days
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects
Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 202318 Sep 2025

First posted12 Apr 2023
Study start3 Oct 2023
Primary completion15 Jul 2024
Study completion18 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 949 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05809596
Sponsor's protocol ID: s2504
Acronym: HEAL-LAA
Status last verified: Oct 2025
First submitted: 30 Mar 2023
Last updated: 4 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy ( https://www.bostonscientific.com/en-US/data-sharing-requests.html).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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OPTION-EMEA Clinical Trial
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A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
ClinicalTrials.gov ID: NCT05809596
Acronym / sponsor ID: HEAL-LAA / s2504
Conditions: Atrial Fibrillation, Bleeding, Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 949 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 3 Oct 2023 (actual)
Primary completion: 15 Jul 2024 (actual)
Study completion: 18 Sep 2025 (actual)
First posted: 12 Apr 2023 (actual)
Results: Posted 15 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Device Group	Other	Device: WATCHMAN FLX Pro LAAC DeviceWATCHMAN FLX Pro LAAC Device Implantation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WATCHMAN FLX Pro LAAC DeviceAlso: Left Atrial Appendage ClosureTreatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device	Device	Device Group

Primary outcome

Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
Time frame: 45 days
Incomplete seal with peri-device gap > 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects
Time frame: 6 months
Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.

Results and safety

Results posted to the registry on 15 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Analysis Subset	500	474

Primary outcome: Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects

Time frame: 45 days. Count of participants. Unit: Participants

Measure	Primary Analysis Subset n = 404
Value	0

Population analysed: Implanted primary analysis subjects with 45-day TEE imaging.

Primary outcome: Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Primary Analysis Subset n = 494
Value	54

Adverse events

Time frame: Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Analysis Subset	141 of 500 (28.2%)	70 of 500 (14%)	16 of 500

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy ( https://www.bostonscientific.com/en-US/data-sharing-requests.html).

Related trials for Atrial Fibrillation

Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruiting
Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
Atrial Fibrillation (AF), Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed Kanj, MD principal investigator

The Cleveland Clinic

Oluseun Alli, MD principal investigator

Novant Health Heart & Vascular Institute

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing WATCHMAN FLX Pro LAAC Device in people with Atrial Fibrillation and Bleeding, run by Boston Scientific Corporation at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05809596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.