HEAL-LAA Clinical Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Boston Scientific Corporation
Study ID
NCT05809596
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • WATCHMAN FLX Pro LAAC Device — DEVICE
    Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device

Study Details

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.

Key Dates

Start date
Oct 3, 2023
Status verified
Oct 2025
Primary completion
Jul 15, 2024
Completion
Sep 18, 2025

Study Design

Enrollment
949 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Device Group
    WATCHMAN FLX Pro LAAC Device Implantation

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 ]

Locations (45)

FacilityCityStateZIPSite coordinators
Grandview Medical Center/ Affinity Cardiovascular SpecialistsBirminghamAlabama35243-
University of Alabama Medical CenterBirminghamAlabama35233-
Phoenix Cardiovascular Research GroupPhoenixArizona85018-
Tucson Medical CenterTucsonArizona85712-
Arrhythmia Research GroupJonesboroArkansas72401-
Scripps Memorial HospitalLa JollaCalifornia92307-
Good Samaritan HospitalLos AngelesCalifornia90017-
Eisenhower Medical CenterRancho MirageCalifornia92270-
Santa Barbara Cottage HospitalSanta BarbaraCalifornia93105-
Los Robles Hospital & Medical CenterThousand OaksCalifornia91360-
UC Health Memorial Hospital CentralColorado SpringsColorado80909-
Cardiology Associates of Fairfield County, P.C.NorwalkConnecticut06851-
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010-
Manatee Memorial HospitalBradentonFlorida34205-
Sarasota Memorial HospitalSarasotaFlorida34239-
Emory UniversityAtlantaGeorgia30342-
Memorial Health University Medical CenterSavannahGeorgia31404-
Straub Medical CenterHonoluluHawaii96813-
Advocate Christ Medical CenterOak LawnIllinois60453-
Community Heart and Vascular HospitalIndianapolisIndiana46250-
University of Kansas Health SystemKansas CityKansas66160-
Brigham and Women's HospitalBostonMassachusetts02115-
Corewell HealthGrand RapidsMichigan49525-
Mayo ClinicRochesterMinnesota55905-
Saint Luke's Health SystemKansas CityMissouri64111-
Nebraska Methodist HospitalOmahaNebraska68114-
Virtua HealthMarltonNew Jersey08053-
Kaleida Health - Gates Vascular InstituteBuffaloNew York14203-
Rochester General HospitalRochesterNew York14621-
Montefiore Medical CenterThe BronxNew York10467-
Novant Health Heart & Vascular InstituteCharlotteNorth Carolina28204-
Sanger Heart and Vascular Institute-Carolinas Medical CenterCharlotteNorth Carolina28204-
Cleveland ClinicClevelandOhio44195-
UPMC Pinnacle Health at Harrisburg HospitalMechanicsburgPennsylvania17050-
WellSpan York HospitalYorkPennsylvania17403-
Erlanger Health, Inc.,ChattanoogaTennessee37403-
Baptist Memorial Hospital-Memphis / Stern Cardiovascular FoundationGermantownTennessee38138-
Ascension Saint ThomasNashvilleTennessee37203-
Centennial Medical CenterNashvilleTennessee37203-
Texas Cardiac Arrhythmia ResearchAustinTexas78705-
Memorial Hermann Memorial City Medical CenterHoustonTexas77094-
Methodist HospitalSan AntonioTexas78229-
Christus Trinity Mother FrancesTylerTexas75701-
St. Mark's HospitalSalt Lake CityUtah84124-
Inova Fairfax HospitalFalls ChurchVirginia22042-

Find similar trials in Birmingham, AL

By condition
Atrial fibrillationStroke
By specialty
CardiologyHeart diseaseNeurologyBrain disorders
By research site
Grandview Medical Center/ Affinity Cardiovascular Specialists· Birmingham, ALUniversity of Alabama Medical Center· Birmingham, ALPhoenix Cardiovascular Research Group· Phoenix, AZTucson Medical Center· Tucson, AZArrhythmia Research Group· Jonesboro, ARScripps Memorial Hospital· La Jolla, CA

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