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Clinical Study of the inQB8 TTVR System

RECRUITINGN/ASponsored by inQB8 Medical Technologies, LLC
Actively Recruiting
PhaseN/A
SponsorinQB8 Medical Technologies, LLC
Started2025-06-01
Est. completion2026-10-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →

NCT06611579

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseTricuspid Valve Regurgitation

Locations6 sites

Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mitch Gheorghiu310-423-6152Mitch.Gheorghiu@cshs.org
Los Robles Hosptial and Medical Center
Thousand Oaks, California, 91360
Mane Arabyan805-796-3746mane.arabyan@hcahealthcare.com
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Caryn Bernstein404-605-5688Caryn.Bernstein@piedmont.org
North Shore University Hospital
Manhasset, New York, 11030
Kristine McGowan516-881-7035KMcGowan@northwell.edu
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Marisa Konig215-662-8456Marisa.Konig@pennmedicine.upenn.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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