Tricuspid Valve Regurgitation
Conditions
Brief summary
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Detailed 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.
Interventions
Replacement of the tricuspid valve using a transcatheter approach
Sponsors
inQB8 Medical Technologies, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of device or procedure related major adverse events | 30 days |
| Change in TR grade from baseline | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device and procedure related complications | 30 days and 12 months | Rate of Device and procedure related complications |
| NYHA functional classification | 30 days, 6 months, 1 year, and through study completion, an average of 1 year | Change in NYHA functional class from baseline |
| Six-minute-walk test | 30 days, 6 months, 1 year, and through study completion, an average of 1 year | Change in distance from baseline |
| Health status - KCCQ | 30 days, 6 months, 1 year, and through study completion, an average of 1 year | Change in quality of life from baseline |
| TR grade | 30 days, 6 months, 1 year, and through study completion, an average of 1 year | Change in TR Grade from baseline |
| Hospitalization | 30 days, 6 months, 1 year, and through study completion, an average of 1 year | Rate of all-cause hospitalization |
Countries
Belgium, Canada, United States
Outcome results
None listed