Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

Part of paid clinical trials in Los Angeles, California.

Sponsor
VDyne, Inc.
Study ID
NCT05848284
Status
Recruiting
Apply to this trial

Conditions

  • Tricuspid Regurgitation
  • Tricuspid Valve Disease
  • Tricuspid Valvular Disorders

Eligibility Criteria

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

Interventions

  • VDyne Transcatheter Tricuspid Valve Replacement System — DEVICE
    The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.

Study Details

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).

Key Dates

Start date
Apr 1, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2031

Study Design

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

Arms

  • Experimental: VDyne System Treatment Arm
    Device

Primary Outcome Measure

The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC). [ Time Frame: Implant to 30 days post-procedure ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Mitch Gheorghiu
[email protected]
3104236152
Raj Makkar (PRINCIPAL_INVESTIGATOR)
Henry Ford HospitalDetriotMichigan48208
Sahar Razmjou
[email protected]
313.916.4475
Brian O'Neill, MD (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Jason Digman
[email protected]
(612) 863-9291
Konstantinos Voudris (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - RochesterRochesterMinnesota55905
Adam Logeman
[email protected]
507-422-2263
Columbia University Medical Center/NYPHNew YorkNew York10032
Treena Williams
[email protected]
2123423485
Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Kara Booth
[email protected]
(718) 920-6523
Edwin Ho, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Belinda Frakes
[email protected]
5135851777
Santiago Garcia (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UnversityPortlandOregon97239
Anna Garwood
[email protected]
503-494-3472
Firas Zahr, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Natalie Drain, MHA
[email protected]
843-876-5037
Nick Amoroso, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. ThomasNashvilleTennessee37205
Erin Beller, BSN, RN
[email protected]
6152226997
Andrew Morse, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAHenry Ford Hospital· Detriot, MIMinneapolis Heart Institute Foundation· Minneapolis, MNMayo Clinic - Rochester· Rochester, MNColumbia University Medical Center/NYPH· New York, NYMontefiore Medical Center· The Bronx, NY

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