Clinical Study of the inQB8 TTVR System
A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
1 other identifier
interventional
50
1 country
6
Brief Summary
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
November 4, 2025
July 1, 2025
1.4 years
September 19, 2024
October 31, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Absence of device or procedure related major adverse events
30 days
Change in TR grade from baseline
30 days
Secondary Outcomes (6)
Device and procedure related complications
30 days and 12 months
NYHA functional classification
30 days, 6 months, 1 year, and through study completion, an average of 1 year
Six-minute-walk test
30 days, 6 months, 1 year, and through study completion, an average of 1 year
Health status - KCCQ
30 days, 6 months, 1 year, and through study completion, an average of 1 year
TR grade
30 days, 6 months, 1 year, and through study completion, an average of 1 year
- +1 more secondary outcomes
Study Arms (1)
Treatment
EXPERIMENTALTreatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
Interventions
Replacement of the tricuspid valve using a transcatheter approach
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Los Robles Hosptial and Medical Center
Thousand Oaks, California, 91360, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Baylor Heart Hospital
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2024
First Posted
September 25, 2024
Study Start
June 1, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2029
Last Updated
November 4, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share