Encore PFO Closure Device - The PerFOrm Trial

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Encore Medical Inc.
Study ID
NCT05537753
Status
Recruiting
Apply to this trial

Conditions

  • Cryptogenic Stroke
  • Patent Foramen Ovale

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Encore PFO closure device — DEVICE
    The Encore PFO closure device comprises an implant component and a single-use delivery system.
  • FDA-approved PFO closure device — DEVICE
    Chosen by the investigator

Study Details

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.

Key Dates

Start date
Jul 12, 2023
Status verified
Sep 2024
Primary completion
Apr 30, 2026
Completion
Oct 31, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Encore PFO closure device
  • Active Comparator: Any FDA-approved PFO closure device chosen by the investigator

Primary Outcome Measure

Safety: The incidence of device- or procedure-related serious adverse events (SAEs) [ Time Frame: 6 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Arkansas CardiologyLittle RockArkansas72205
Bobbi Phillips
[email protected]
Erika Jaco
[email protected]
Ernesto Ruiz-Rodriguez, MD (PRINCIPAL_INVESTIGATOR)
Thomas Evans Watts, MD (SUB_INVESTIGATOR)
Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial HospitalLa JollaCalifornia92037
Sharon Weaver
[email protected]
858-824-8261
Kirsten Wade
[email protected]
858-824-8263
Jeffrey Cavendish, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Osama Abou Saleh, MD
[email protected]
813-259-8835
Vlastibor Minarovjech
[email protected]
Bibhu Mohanty, MD (PRINCIPAL_INVESTIGATOR)
Mercy One Iowa Heart CenterWest Des MoinesIowa50266
Jennifer Young, RN
[email protected]
Emily Plock
[email protected]
Mark Tannenbaum, MD (PRINCIPAL_INVESTIGATOR)
Kansas University Medical CenterKansas CityKansas66160
Tilitha Shawgo, RN
[email protected]
913-588-9720
Emily Work
[email protected]
913-588-2613
Georges Hajj, MD (PRINCIPAL_INVESTIGATOR)
Eric Hockstad, MD (SUB_INVESTIGATOR)
Jackson Heart ClinicJacksonMississippi39216
Jamie Neal
[email protected]
601-982-7850
Sandy Puckett
[email protected]
601-982-7850
William Crowder, MD (PRINCIPAL_INVESTIGATOR)
CHI HealthOmahaNebraska68124
Barb Lapke
[email protected]
402-343-8511
Mel Romsa
[email protected]
402-343-8511
Himanshu Agarwal, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina Gazes Research InstituteCharlestonSouth Carolina29425
Virginia Theodorof
[email protected]
Kavin Panneerselvam
[email protected]
Christopher D Nielsen, MD (PRINCIPAL_INVESTIGATOR)

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Arkansas Cardiology· Little Rock, ARSouthern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital· La Jolla, CAUniversity of South Florida· Tampa, FLMercy One Iowa Heart Center· West Des Moines, IAKansas University Medical Center· Kansas City, KSJackson Heart Clinic· Jackson, MS

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