Tricuspid Valve RegurgitationNCT06611579
Clinical Study of the inQB8 TTVR System (The MonarQ Study)
A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Valve Regurgitation, run by inQB8 Medical Technologies, LLC at 8 sites in 3 countries.
Trial summary
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation
- What is being tested?
- Transcatheter Tricuspid Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 1 Jun 2025to 31 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States6 sites, 6 recruiting
- Recruiting
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Caryn Bernstein, 404-605-5688, Caryn.Bernstein@piedmont.org
Pradeep Yadav
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mitch Gheorghiu, 310-423-6152, Mitch.Gheorghiu@cshs.org
Raj Makkar
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Kristine McGowan, 516-881-7035, KMcGowan@northwell.edu
Bruce Rutkin
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Marisa Konig, 215-662-8456, Marisa.Konig@pennmedicine.upenn.edu
Wilson Szeto
- Recruiting
Baylor Heart Hospital
Plano, Texas, 75093
Saba Ilyas, 469-814-4853, Saba.Ilyas@bswhealth.org
Robert Smith
- Recruiting
Los Robles Hosptial and Medical Center
Thousand Oaks, California, 91360
Mane Arabyan, 805-796-3746, mane.arabyan@hcahealthcare.com
Saibal Kar
Belgium1 site, 1 recruiting
- Recruiting
AZ Sint-Jan Brugge AV
Bruges, 8000
Katrien Derycker, +32 (0) 50 453896, Katrien.Derycker@azsintjan.be
Jan Van der Heyden
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Alana Harrington, 416-864-6060 ext. 49003, Alana.Harrington@unityhealth.to
Neil Fam
About this study
Official title: A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Read the 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.
- Conditions
- Tricuspid Valve Regurgitation
- Being tested
- Transcatheter Tricuspid Valve Replacement
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Tricuspid Valve ReplacementDevice
Also called inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
Replacement of the tricuspid valve using a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System Receives: Device: Transcatheter Tricuspid Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of device or procedure related major adverse events
Measured: 30 days
Change in TR grade from baseline
Measured: 30 days
Secondary outcomes (6)
Device and procedure related complications
Rate of Device and procedure related complications
Measured: 30 days and 12 months
NYHA functional classification
Change in NYHA functional class from baseline
Measured: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Six-minute-walk test
Change in distance from baseline
Measured: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Health status - KCCQ
Change in quality of life from baseline
Measured: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
TR grade
Change in TR Grade from baseline
Measured: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Hospitalization
Rate of all-cause hospitalization
Measured: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jun 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- inQB8 Medical Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611579
- Sponsor's protocol ID
- CIP-21001
- Status last verified
- May 2026
- First submitted
- 19 Sep 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
- ClinicalTrials.gov ID
- NCT06611579
- Acronym / sponsor ID
- CIP-21001
- Conditions
- Tricuspid Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- inQB8 Medical Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcatheter Tricuspid Valve ReplacementTreatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Tricuspid Valve ReplacementAlso: inQB8 MonarQ Transcatheter Tricuspid Valve Replacement SystemReplacement of the tricuspid valve using a transcatheter approach | Device | Treatment |
Primary outcome
Absence of device or procedure related major adverse events
Time frame: 30 days
Change in TR grade from baseline
Time frame: 30 days
6 secondary outcomes
Device and procedure related complications
Time frame: 30 days and 12 months
NYHA functional classification
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Six-minute-walk test
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Health status - KCCQ
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
TR grade
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Hospitalization
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Valve Regurgitation
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Not yet recruiting
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Los Robles Hosptial and Medical Center
Thousand Oaks, United States
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Valve Regurgitation, run by inQB8 Medical Technologies, LLC at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of device or procedure related major adverse events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.