EFS of the DUO System for Tricuspid Regurgitation

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
CroiValve Limited
Study ID
NCT05913908
Status
Recruiting
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Conditions

  • Heart Valve Diseases
  • Tricuspid Regurgitation
  • Tricuspid Valve Disease
  • Tricuspid Valve Insufficiency

Eligibility Criteria

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

Interventions

  • DUO Transcatheter Tricuspid Coaptation Valve System — DEVICE
    Reduction of tricuspid regurgitation through a transcatheter approach

Study Details

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Key Dates

Start date
Aug 13, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)

Primary Outcome Measure

Freedom from device or procedure related MAEs [ Time Frame: At 30 days ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Dignity Health St. Joseph's Hospital & Medical CenterPhoenixArizona85013
Valerie Colores
[email protected]
602-406-8772
Hursh Naik, MD (PRINCIPAL_INVESTIGATOR)
Los Robles Hospital & Medical CenterThousand OaksCalifornia91360
Mane Arabyan
[email protected]
805.796.3746
Saibal Kar, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Heart InstituteAtlantaGeorgia30309
Danielle Griffith
[email protected]
Pradeep Yadav, MD (PRINCIPAL_INVESTIGATOR)
Vinod Thourani, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Charles Davidson, MD (PRINCIPAL_INVESTIGATOR)
Ascension Via Christi ResearchWichitaKansas67214
Lindsey Steele
[email protected]
Bassem Chehab, MD (PRINCIPAL_INVESTIGATOR)
Allina Health Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Kate Jappe
[email protected]
612.863.7601
Paul Sorajja, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center/NYPHNew YorkNew York10032
Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR)
OhioHealth Research InstituteColumbusOhio43214
Emily Sudnick
Carlos Sanchez, MD (PRINCIPAL_INVESTIGATOR)
Steven Yakubov, MD (PRINCIPAL_INVESTIGATOR)
UPMC Pinnacle HarrisburgHarrisburgPennsylvania17050
Brittany Mashuda, BSN, RN, CHFN
[email protected]
717-782-5904
Hemal Gada, MD (PRINCIPAL_INVESTIGATOR)
San Antonio MethodistSan AntonioTexas78229-
Intermountain HealthSalt Lake CityUtah84111
Lindsay Bosh Bosh
[email protected]
801-507-4759
Brian Whisenant, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Ray Larsen
[email protected]
206-221-1665
James McCabe MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dignity Health St. Joseph's Hospital & Medical Center· Phoenix, AZLos Robles Hospital & Medical Center· Thousand Oaks, CAPiedmont Heart Institute· Atlanta, GANorthwestern University· Chicago, ILAscension Via Christi Research· Wichita, KSAllina Health Minneapolis Heart Institute Foundation· Minneapolis, MN

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