Clinical Study of the inQB8 TTVR System (The MonarQ Study)

Part of paid clinical trials in Los Angeles, California.

Sponsor
inQB8 Medical Technologies, LLC
Study ID
NCT06611579
Status
Recruiting
Apply to this trial

Conditions

  • Tricuspid Valve Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcatheter Tricuspid Valve Replacement — DEVICE
    Replacement of the tricuspid valve using a transcatheter approach

Study Details

Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

Key Dates

Start date
Jun 1, 2025
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

Primary Outcome Measure

Absence of device or procedure related major adverse events [ Time Frame: 30 days ]

Locations (6)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Mitch Gheorghiu
[email protected]
310-423-6152
Raj Makkar (PRINCIPAL_INVESTIGATOR)
Los Robles Hosptial and Medical CenterThousand OaksCalifornia91360
Mane Arabyan
[email protected]
805-796-3746
Saibal Kar (PRINCIPAL_INVESTIGATOR)
Piedmont Atlanta HospitalAtlantaGeorgia30309
Caryn Bernstein
[email protected]
404-605-5688
Pradeep Yadav (PRINCIPAL_INVESTIGATOR)
North Shore University HospitalManhassetNew York11030
Kristine McGowan
[email protected]
516-881-7035
Bruce Rutkin (PRINCIPAL_INVESTIGATOR)
Elana Koss (PRINCIPAL_INVESTIGATOR)
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104
Marisa Konig
[email protected]
215-662-8456
Wilson Szeto (PRINCIPAL_INVESTIGATOR)
Baylor Heart HospitalPlanoTexas75093
Saba Ilyas
[email protected]
469-814-4853
Robert Smith (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CALos Robles Hosptial and Medical Center· Thousand Oaks, CAPiedmont Atlanta Hospital· Atlanta, GANorth Shore University Hospital· Manhasset, NYPenn Presbyterian Medical Center· Philadelphia, PABaylor Heart Hospital· Plano, TX

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