Recruiting

inQB8 TTVR

Sponsor:

inQB8 Medical Technologies, LLC

Code:

NCT06611579

Conditions

Tricuspid Valve Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Tricuspid Valve Replacement

Study Details

Brief summary:

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

Conditions

Tricuspid Valve Regurgitation

Study ID

NCT06611579

Start date

Jun 1, 2025

Status verified date

May, 2026

Completion date

Oct 31, 2030

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

Interventions

Transcatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve using a transcatheter approach

Primary outcome measure

  • Absence of device or procedure related major adverse events [ Time Frame: 30 days ]
  • Change in TR grade from baseline [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Mitch Gheorghiu

310-423-6152Mitch.Gheorghiu@cshs.org

Principal Investigator:

Raj Makkar

Los Robles Hosptial and Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Mane Arabyan

805-796-3746mane.arabyan@hcahealthcare.com

Principal Investigator:

Saibal Kar

Piedmont Atlanta Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Caryn Bernstein

404-605-5688Caryn.Bernstein@piedmont.org

Principal Investigator:

Pradeep Yadav

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Kristine McGowan

516-881-7035KMcGowan@northwell.edu

Principal Investigator:

Bruce Rutkin

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Marisa Konig

215-662-8456Marisa.Konig@pennmedicine.upenn.edu

Principal Investigator:

Wilson Szeto

Baylor Heart Hospital

Recruiting

Plano, Texas, United States, 75093

Contacts

Saba Ilyas

469-814-4853Saba.Ilyas@bswhealth.org

Principal Investigator:

Robert Smith

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Alana Harrington

416-864-6060Alana.Harrington@unityhealth.to

Principal Investigator:

Neil Fam

More Information

Sponsor

inQB8 Medical Technologies, LLC

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by inQB8 Medical Technologies, LLC on 2026-05-18.