Clinical Study of the inQB8 TTVR System (The MonarQ Study)
ConditionTricuspid Valve Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorinQB8 Medical Technologies, LLC
About this trial
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transcatheter Tricuspid Valve Replacement
DeviceReplacement of the tricuspid valve using a transcatheter approach
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Absence of device or procedure related major adverse events
Time frame
30 days2
Change in TR grade from baseline
Time frame
30 daysSecondary outcomes
1
Device and procedure related complications
Rate of Device and procedure related complications
Time frame
30 days and 12 months2
NYHA functional classification
Change in NYHA functional class from baseline
Time frame
30 days, 6 months, 1 year, and through study completion, an average of 1 year3
Six-minute-walk test
Change in distance from baseline
Time frame
30 days, 6 months, 1 year, and through study completion, an average of 1 year4
Health status - KCCQ
Change in quality of life from baseline
Time frame
30 days, 6 months, 1 year, and through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov