A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Los Robles Hosptial and Medical Center
RECRUITING
Thousand Oaks
Georgia
Piedmont Atlanta Hospital
RECRUITING
Atlanta
New York
North Shore University Hospital
RECRUITING
Manhasset
Pennsylvania
Penn Presbyterian Medical Center
RECRUITING
Philadelphia
Texas
Baylor Heart Hospital
RECRUITING
Plano
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 50
Treatments
Experimental: Treatment
Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
Related Therapeutic Areas
Sponsors
Leads: inQB8 Medical Technologies, LLC