Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Study ID
NCT06436924
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Left Atrial Appendage Device Implant — DEVICE
    The Watchman Device is implanted into the left atrial appendage and is designed to close it off and keep blood clots from escaping that area.

Study Details

SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.

Key Dates

Start date
May 14, 2024
Status verified
Oct 2025
Primary completion
Dec 30, 2025
Completion
Mar 30, 2026

Study Design

Enrollment
678 participants (estimated)

Arms

  • Arm: Subjects undergoing LAAO device implant
    Watchman LAAO device implant

Primary Outcome Measure

Peri-procedural complications [ Time Frame: Procedure through discharge, an average of 1-3 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Grandview Medical CenterBirminghamAlabama35243
Clinical Research Manager
[email protected]
205-971-7578
Anil Rajendra, MD (PRINCIPAL_INVESTIGATOR)
Pima Heart and VascularTucsonArizona85704
Monica Varela
520-838-3540
Aleksander Herber
Thomas Waggoner, MD (PRINCIPAL_INVESTIGATOR)
The Medical Center of AuroraAuroraColorado80012
Chris Dutka, Research Coordinator
Christopher Porterfield, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. VincentJacksonvilleFlorida32204
Research Manager
[email protected]
904-308-1229
Anthony Magnano, MD (PRINCIPAL_INVESTIGATOR)
Naples Community HospitalNaplesFlorida34102
Kathy Byrd
239-624-4200
Dinesh Sharma, M.D. (PRINCIPAL_INVESTIGATOR)
Memorial Health University Medical CenterSavannahGeorgia31404
Lindsey Lamb, MHSA
[email protected]
912-350-9032
Ritzie A Trinidad, MBA
[email protected]
912-350-3110
Todd Senn, MD (PRINCIPAL_INVESTIGATOR)
David Newton, MD (SUB_INVESTIGATOR)
Medical University of South CarolinaColumbiaSouth Carolina29204
Jacqueline Sheriod-Scott
803-409-7175
Barbara Burrell
Loren Morgan, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Grandview Medical Center· Birmingham, ALPima Heart and Vascular· Tucson, AZThe Medical Center of Aurora· Aurora, COAscension St. Vincent· Jacksonville, FLNaples Community Hospital· Naples, FLMemorial Health University Medical Center· Savannah, GA

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