A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
P+F Products + Features USA Inc.
Study ID
NCT06458907
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • TricValve System — DEVICE
    • Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy
  • Optimal medical therapy — DRUG
    Optimal medical therapy

Study Details

Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.

Key Dates

First listed
Jun 14, 2024
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2032

Study Design

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

Arms

  • Experimental: TricValve System + Optimal medical therapy (OMT)
    Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy (OMT) in patients with caval reflux and tricuspid regurgitation.
  • Active Comparator: Optimal medical therapy (OMT) Alone
    OMT alone in patients with caval reflux and tricuspid regurgitation
  • Experimental: TricValve Single Arm Registry
    Single-Arm Registry for Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with OMT in patients with caval reflux and tricuspid regurgitation who are not eligible for randomization

Primary Outcome Measure

Randomized Cohort: Caval Reflux (CR) grade reduction [ Time Frame: 6 months ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233-
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
UC Davis HealthSacramentoCalifornia95817-
Scripps Memorial Hospital La JollaSan DiegoCalifornia92037-
UCSFSan FranciscoCalifornia94143-
Kaiser PermanenteSan JoseCalifornia94118-
MedStar Washington Hospital Center (MWHC)Washington D.C.District of Columbia20010
Erin Collins
Toby Rogers, MD (PRINCIPAL_INVESTIGATOR)
Delray Medical CenterDelray BeachFlorida33484-
HCA Florida Largo HospitalLargoFlorida33770
Saurabh Sanon, MD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606-
Endeavor HealthGlenviewIllinois60026-
Ascension Medical Group St. Vincent The Heart Center of IndianaIndianapolisIndiana46260-
University of Kansas Medical CenterKansas CityKansas66103-
Cardiovascular Institute of the SouthHoumaLouisiana70360-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-
Saint Luke's Mid America Heart InstituteKansas CityMissouri64111-
Washington University of St LouisSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Northwell HospitalManhassetNew York11030-
Montefiore Medical CenterThe BronxNew York10467-
Cleveland ClinicClevelandOhio44106
Rishi Puri, MD (PRINCIPAL_INVESTIGATOR)
Riverside Methodist HospitalColumbusOhio43214-
Oregon HealthPortlandOregon97239-
MUSCCharlestonSouth Carolina29425-
Houston MethodistHoustonTexas77030-
University of Texas (Memorial Hermann)HoustonTexas77030-
Baylor Scott & White MedicalPlanoTexas75093-
Intermountain Heart Institute - Intermountain Medical CenterMurrayUtah84107-
UVA School of MedicineCharlottesvilleVirginia22903-
Sentara HealthcareNorfolkVirginia23507-
Carilion ClinicRoanokeVirginia24014-

Find similar trials in Birmingham, AL

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By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Alabama· Birmingham, ALSt. Joseph's Hospital and Medical Center· Phoenix, AZUC Davis Health· Sacramento, CAScripps Memorial Hospital La Jolla· San Diego, CAUCSF· San Francisco, CAKaiser Permanente· San Jose, CA

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