Clinical Study of the InQB8 TTVR System

inQB8 Medical Technologies, LLC

Status: Not yet enrolling

Conditions: Tricuspid Valve Regurgitation

Treatments: Device: Transcatheter Tricuspid Valve Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06611579

CIP-21001

Details and patient eligibility

About

Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

Full description

The study is a multi-center, prospective, single-arm study to assess safety and performance of the inQB8 Medical Technologies MonarQ Tricuspid Valve Replacement System.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anatomically suitable for the MonarQ TTVR System
• Symptomatic, tricuspid regurgitation (TR) that is severe or greater
• Adequately treated for heart failure based upon medical standards
• Hemodynamically stable

Exclusion criteria

• Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
• Refractory Heart Failure (HF) that requires or required advanced intervention
• Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.
• Currently participating in another investigational biologic, drug or device study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

Treatment:

Device: Transcatheter Tricuspid Valve Replacement