Clinical Study of the inQB8 TTVR System (The MonarQ Study) | NCT06611579

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

NCT06611579

Sponsor

inQB8 Medical Technologies, LLC

Status

Recruiting

Last Update Posted

May 18, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Tricuspid Valve Regurgitation

Interventions

Transcatheter Tricuspid Valve Replacement

Countries

United States
Belgium
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Oct 31, 2027Estimated

Completion Date

Oct 31, 2030Estimated

First Submitted Date

Sep 19, 2024

First Submission Date that Met QC Criteria

Sep 20, 2024

First Posted Date

Sep 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter Tricuspid Valve Replacement	Device	Replacement of the tricuspid valve using a transcatheter approach	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absence of device or procedure related major adverse events		30 days
Change in TR grade from baseline		30 days

Secondary Outcomes

Measure	Description	Time Frame
Device and procedure related complications	Rate of Device and procedure related complications	30 days and 12 months
NYHA functional classification	Change in NYHA functional class from baseline

Other Outcomes

Not provided

Eligibility Module

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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center	Recruiting	Los Angeles	California	90048	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided