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
Qualifiers
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
Treatments tested in this trial
- Transcatheter Tricuspid Valve Replacement
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov