Clinical Study of the inQB8 TTVR System

Phase

N/A

Condition

N/A

Treatment

Transcatheter Tricuspid Valve Replacement

Clinical Study ID

NCT06611579

CIP-21001

Ages > 18
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Need for emergent or urgent surgery for any reason, any planned cardiac surgerywithin the next 12 months (365 days), or any planned percutaneous cardiac procedurewithin 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 patientwill be able to complete all protocol procedures and follow-up.
Currently participating in another investigational biologic, drug or device study

Study Design

Transcatheter Tricuspid Valve Replacement

June 01, 2025

October 31, 2029

Study 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.

Connect with a study center

Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Site Not Available
Los Robles Hosptial and Medical Center
Thousand Oaks, California 91360
United States
Site Not Available
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United States
Active - Recruiting
Los Robles Hosptial and Medical Center
Thousand Oaks 5402405, California 5332921 91360
United States
Active - Recruiting
Piedmont Atlanta Hospital
Atlanta 4180439, Georgia 4197000 30309
United States
Active - Recruiting
North Shore University Hospital
Manhasset, New York 11030
United States
Site Not Available
North Shore University Hospital
Manhasset 5125766, New York 5128638 11030
United States
Active - Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United States
Site Not Available
Penn Presbyterian Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104
United States
Active - Recruiting
Baylor Heart Hospital
Plano, Texas 75093
United States
Site Not Available
Baylor Heart Hospital
Plano 4719457, Texas 4736286 75093
United States
Active - Recruiting

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