Clinical Study of the inQB8 TTVR System (The MonarQ Study)
Recruiting
N/A
Interventional Study
Tricuspid Valve Regurgitation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- inQB8 Medical Technologies, LLC · Industry
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About This Trial
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Trial Locations
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Eligibility Criteria
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 a…
Contacts
No contact information available.