TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TricValve® Transcatheter Bicaval Valve System — DEVICE
  The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The system is a single use, sterile device compatible with all the valve sizes. The valves are premounted in the TricValve® Delivery System. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system available in sizes 25 and 29 for superior vena cava and 31 and 35 for inferior vena cava. The valve is implanted percutaneously by the transfemoral approach. The valves are supplied already premounted into the TricValve® Delivery System.

Study Details

The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

Key Dates

Start date

Jul 23, 2024

Status verified

Jun 2025

Primary completion

Nov 30, 2025

Completion

Sep 30, 2029

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: TricValve® Device (Device) Group
  subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.

Primary Outcome Measure

Mortality [ Time Frame: 1 Month and 12 Months ]

Central Contacts

• Monica Tocchi, MD, PhD
  9176841700
  [email protected]

Locations (36)

Find similar trials in Phoenix, AZ

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