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)

FacilityCityStateZIP
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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