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NCT05913908ClinicalTrials.gov

EFS of the DUO System for Tricuspid Regurgitation

Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

RecruitingTaking participants now, according to the registry record.
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In brief

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Interventional15 participants sought15 sites2 countries

Categories

Cardiovascular100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2023-06-22; recorded start 2024-08-13
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (CroiValve Limited)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 4 conditions.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 15 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScalePILOT

A pilot-scale study, international in scope: 15 participants (target), run at 15 sites, across 2 countries.

How this score is built
  • Enrolment9/40

    15 participants (target)

  • Site count14/25

    15 sites

  • Country count7/15

    2 countries

  • Planned duration10/10

    Planned over about 63 months

  • Sponsor scale1/10

    CroiValve Limited has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.

Conditions

  • Tricuspid Regurgitation
  • Tricuspid Valve Insufficiency
  • Heart Valve Diseases
  • Tricuspid Valve Disease

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

Inclusion Criteria: 1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab. 2. Patient is symptomatic despite medical therapy. 3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention. 4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee. 5. Age ≥18 years 6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent. Exclusion Criteria: 1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial. 2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device. 3. Moderate or greater tricuspid valve stenosis. 4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation 5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device. 6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair). 7. Ejection Fraction (EF) \<25% 8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation 9. Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg 10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices 11. Severe respiratory instability with continuous use of home oxygen 12. Severe right ventricular dysfunction 13. Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI. 14. Stroke or transient ischemic event within 90 days prior to the index procedure 15. Acute myocardial infarction within 30 days before the index procedure 16. Renal insufficiency (eGFR \<25 ml/min) or currently on chronic dialysis 17. Active endocarditis within 6 months of the index procedure 18. Pulmonary embolism or deep vein thrombosis within the last 6 months 19. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure 20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis 21. Life expectancy \<1 year 22. Active infections requiring current antibiotic therapy 23. Known severe liver disease 24. Is on the waiting list for a transplant or has had a prior heart or lung transplant 25. Known active peptic ulcer or active GI bleed 26. Unable to take anticoagulant therapy 27. Any known major coagulation abnormalities, thrombocytopenia, platelets \< 50,000/ml or severe anemia Hb \<8 g/dl 28. Known patient is actively abusing drugs 29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium 30. Patients who are pregnant or intend to become pregnant 31. Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhaseNot applicable
AllocationNot applicable
Intervention modelSINGLE_GROUP
Primary purposeTREATMENT
MaskingNONE (0)
Enrolment15 participants sought

Sponsor and collaborators

  • CroiValve Limited Sponsor

Arms and interventions

  • TreatmentEXPERIMENTAL

    Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)

Interventions

  • Device DUO Transcatheter Tricuspid Coaptation Valve System

    Reduction of tricuspid regurgitation through a transcatheter approach

Outcome measures

  1. Primary outcome

    Freedom from device or procedure related MAEs

    * Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism

    Time frame At 30 days

Dates

Start dateAugust 13, 2024 (actual)
Primary completionDecember 1, 2027 (estimated)
CompletionOctober 1, 2029 (estimated)
First postedJune 22, 2023 (actual)
Last updatedJune 1, 2026
Results postedNot stated in the registry record
Status last verifiedMay 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

14 sites are recruiting

Poland

FacilityCityState or regionStatus
Medical University of SilesiaKatowiceRecruiting
Uniwersytetem Medycznym im. Karola Marcinkowskiego w PoznaniuPoznanPoznanRecruiting
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem BadawczymWarsawWarsawRecruiting

United States

FacilityCityState or regionStatus
Piedmont Heart InstituteAtlantaGeorgiaRecruiting
Northwestern UniversityChicagoIllinoisRecruiting
OhioHealth Research InstituteColumbusOhioRecruiting
UPMC Pinnacle HarrisburgHarrisburgPennsylvaniaRecruiting
Allina Health Minneapolis Heart Institute FoundationMinneapolisMinnesotaRecruiting
Columbia University Medical Center/NYPHNew YorkNew YorkRecruiting
Dignity Health St. Joseph's Hospital & Medical CenterPhoenixArizonaRecruiting
Intermountain HealthSalt Lake CityUtahRecruiting
San Antonio MethodistSan AntonioTexasNot stated
University of WashingtonSeattleWashingtonRecruiting
Los Robles Hospital & Medical CenterThousand OaksCaliforniaRecruiting
Ascension Via Christi ResearchWichitaKansasRecruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05913908