PULSED AF Post-Approval Study

Part of paid clinical trials in Tampa, Florida.

Sponsor
Medtronic Cardiac Ablation Solutions
Study ID
NCT06578104
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • PulseSelect™ PFA system — DEVICE
    Ablation using the PulseSelect™ PFA system

Study Details

PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Key Dates

Start date
Nov 4, 2024
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2029

Study Design

Enrollment
580 participants (estimated)

Arms

  • Arm: Paroxysmal
    Ablation using the PulseSelect™ PFA system
  • Arm: Persistent
    Ablation using the PulseSelect™ PFA system

Primary Outcome Measure

Efficacy-Freedom from Atrial Fibrillation [ Time Frame: 36-months after the index ablation procedure ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
University of South Florida Health (USF)TampaFlorida33606-3603
David Wilson
[email protected]
(813) 821-8001
Piedmont Heart InstituteAtlantaGeorgia30309
Reza Karimianpour
[email protected]
4046052800
Megan Kopp
[email protected]
Reza Karimianpour, DO (PRINCIPAL_INVESTIGATOR)
Endeavor Health Swedish HospitalChicagoIllinois60625
Hany Demo, MD
[email protected]
3472160095
Marisa Durante
[email protected]
8475036454
Hany Demo, MD (PRINCIPAL_INVESTIGATOR)
Pikeville Medical CenterWhitesburgKentucky41858-7428
Joseph Souza, MD
[email protected]
(828) 274-6000
Southcoast Health SystemFall RiverMassachusetts02720
Nitesh Sood, MD
[email protected]
Beaumont Health SystemRoyal OakMichigan48073-
Nebraska Medical CenterOmahaNebraska68198
Jason Payne, MD
[email protected]
Northwell Health Lenox Hill HospitalNew YorkNew York10075
Stavros Mountantonakis, MD
[email protected]
(212) 434-6500
The Valley HospitalNew YorkNew York10025
Suneet Mittal, MD
[email protected]
(201) 432-7837
Duke University Medical Center (DUMC)DurhamNorth Carolina27710
Kevin Jackson
(919) 684-8111
Bethesda North HospitalCincinnatiOhio45220
Gaurang Gandhi, MD
[email protected]
5137459800
The Ohio State University Wexner Medical CenterColumbusOhio045218
John Hummel
[email protected]
(614) 293-4967
Mount Carmel Grove City Medical CenterGrove CityOhio43123
Jianqing Li, MD
[email protected]
(614) 627-2000
Doylestown Health Cardiology a division of Doylestown Health PhysiciansDoylestownPennsylvania18901-2554
Robert Sangrigoli, MD
[email protected]
267-893-6800
AnMed Health CenterAndersonSouth Carolina29621
Rick Henderson, MD
[email protected]
(336) 716-8636
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-8908
Rachel Kaplan, MD
[email protected]
(843) 792-2300
Texas Health Research & Education InstituteDallasTexas75231-3815
Charles Lampe, MD
[email protected]
(214) 915-0507
University of Virginia Medical CenterCharlottesvilleVirginia22908
Michael Mangrum, MD
[email protected]
(434) 924-3817

Find similar trials in Tampa, FL

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
University of South Florida Health (USF)· Tampa, FLPiedmont Heart Institute· Atlanta, GAEndeavor Health Swedish Hospital· Chicago, ILPikeville Medical Center· Whitesburg, KYSouthcoast Health System· Fall River, MABeaumont Health System· Royal Oak, MI

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