The Fourth Left Atrial Appendage Occlusion Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hamilton Health Sciences Corporation
Study ID
NCT05963698
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • WATCHMAN device — DEVICE
    Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Study Details

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Key Dates

Start date
Nov 30, 2023
Status verified
Jun 2026
Primary completion
Sep 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: WATCHMAN device
    Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
  • No Intervention: Standard Care
    Participants will receive local, standard medical care

Primary Outcome Measure

Ischemic stroke or systemic embolism [ Time Frame: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). ]

Central Contacts

Locations (51)

FacilityCityStateZIPSite coordinators
Affinity Hospital dba Grandview Medical CenterBirminghamAlabama35243-
Arrhythmia Research GroupJonesboroArkansas72401
Devi Nair, MD (PRINCIPAL_INVESTIGATOR)
Memorial Health ServicesFountain ValleyCalifornia92708
Nikhil Warrier, MD (PRINCIPAL_INVESTIGATOR)
Loma Linda University HealthLoma LindaCalifornia92354
Rahul Bhardwaj, MD (PRINCIPAL_INVESTIGATOR)
Southern California Permanente Medical GroupPasadenaCalifornia91101
Bahram Khadivi, MD (PRINCIPAL_INVESTIGATOR)
Sutter Valley Hospitals dba Sutter Institute for Medical ResearchSacramentoCalifornia95816
David Roberts, MD (PRINCIPAL_INVESTIGATOR)
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK HospitalAtlantisFlorida33462
Marcelo Jimenez, MD (PRINCIPAL_INVESTIGATOR)
St. Vincent's Health SystemJacksonvilleFlorida32204
Saumil Oza, MD (PRINCIPAL_INVESTIGATOR)
Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical CenterLargoFlorida33770
Jesse Klein, MD (PRINCIPAL_INVESTIGATOR)
HCA Florida Ocala HospitalOcalaFlorida34471
Gregory Von Mering, MD (PRINCIPAL_INVESTIGATOR)
The University of South FloridaTampaFlorida33620
Bibhu Mohanty, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
David De Lurgio, MD (PRINCIPAL_INVESTIGATOR)
St Luke's Regional Medical Center, LtdBoiseIdaho83712
Marcos Daccarett, MD (PRINCIPAL_INVESTIGATOR)
Kootenai Health Inc.Coeur d'AleneIdaho83814
Michele Murphy-Cook, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityEvanstonIllinois60208
Albert Lin, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Medicine, PLLC and Unity Point Trinity Rock IslandRock IslandIllinois61201
Mark Shen, MD (PRINCIPAL_INVESTIGATOR)
Community Health Network Inc.IndianapolisIndiana46256
Krishna Malineni, MD (PRINCIPAL_INVESTIGATOR)
MercyOne Iowa Heart CenterWest Des MoinesIowa50266
Pitayadet Jumrussirikul, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical Center Research Institute, Inc.Kansas CityKansas66160
Madhu Reddy, MD (PRINCIPAL_INVESTIGATOR)
Babtist Health LexingtonLexingtonKentucky40503
Gery Tomassoni, MD (PRINCIPAL_INVESTIGATOR)
Ochsner Clinic FoundationNew OrleansLouisiana70121
Richard Zweifler, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland BaltimoreBaltimoreMaryland21201
Seemant Chaturvedi, MD (PRINCIPAL_INVESTIGATOR)
Lahey Clinic Inc.BurlingtonMassachusetts01805
Bruce Hook, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Hakan Oral, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Waddah Maskoun, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Amir Kaki, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Eugene L. Scharf, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Taya Glotzer, MD (PRINCIPAL_INVESTIGATOR)
Presbyterian Healthcare Services d.b.a. Presbyterian Heart GroupAlbuquerqueNew Mexico87106
Sharif Halim, MD (PRINCIPAL_INVESTIGATOR)
The Feinstein Institutes for Medical ResearchManhassetNew York11030
Jeffrey Katz, MD (PRINCIPAL_INVESTIGATOR)
Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian HospitalNew YorkNew York10065
Christopher Liu, MD (PRINCIPAL_INVESTIGATOR)
NYU Grossman School of MedicineNew YorkNew York10065-
Mission Hospital HCAAshevilleNorth Carolina28801
John Rhyner, MD (PRINCIPAL_INVESTIGATOR)
Aultman HospitalCantonOhio44710
Firas Hamdan, MD (PRINCIPAL_INVESTIGATOR)
TriHealth Inc.CincinnatiOhio45202
Gaurang Gandhi, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45221
Srinivas Rajsheker, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Oussama Wazni, MD (PRINCIPAL_INVESTIGATOR)
Saint Francis HospitalTulsaOklahoma74136
Tom Hu, MD (PRINCIPAL_INVESTIGATOR)
The Pennsylvania State University and The Milton S. Hershey Medical CenterHersheyPennsylvania17033
Soraya Samii, MD (PRINCIPAL_INVESTIGATOR)
The Trustees of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Steven Messe, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular InstitutePittsburghPennsylvania15213
Sandeep Jain, MD (PRINCIPAL_INVESTIGATOR)
Rhode Island HospitalProvidenceRhode Island02903
Ana-Lucia Garcia-Guarniz, MD (PRINCIPAL_INVESTIGATOR)
Glanecare, Inc. d/b/a HCA Florida Brandon HospitalBrentwoodTennessee37027
Umesh Gowda, MD (PRINCIPAL_INVESTIGATOR)
The University of TennesseeMemphisTennessee38163
Balaji Krishnaiah, MD (PRINCIPAL_INVESTIGATOR)
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
Baylor Research InstituteDallasTexas75204
Praveen Rao, MD (PRINCIPAL_INVESTIGATOR)
Heart Rhythm AssociatesThe WoodlandsTexas77380-
CHRISTUS Northeast Texas Health SystemTylerTexas75701-2263
Stanislav Weiner, MD (PRINCIPAL_INVESTIGATOR)
The Rector and Visitors of the University of VirginiaCharlottesvilleVirginia22903
Rohit Malhotra, MD (PRINCIPAL_INVESTIGATOR)
CommonSpirit Health Research InstituteTacomaWashington98405
Nasir Shariff, MD (PRINCIPAL_INVESTIGATOR)
The Medical College of WisconsinMilwaukeeWisconsin53226
James Oujiri, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Affinity Hospital dba Grandview Medical Center· Birmingham, ALArrhythmia Research Group· Jonesboro, ARMemorial Health Services· Fountain Valley, CALoma Linda University Health· Loma Linda, CASouthern California Permanente Medical Group· Pasadena, CASutter Valley Hospitals dba Sutter Institute for Medical Research· Sacramento, CA

Related Studies