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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

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).

Interventistico15 partecipanti ricercati15 centri2 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

ClinicalTrials.govNCT05913908Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

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

Sintesi

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.

Patologie

Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Heart Valve Diseases
Tricuspid Valve Disease

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel registro

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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Non applicabile
Assegnazione	Non applicabile
Modello di intervento	SINGLE_GROUP
Finalità principale	TREATMENT
Mascheramento	NONE (0)
Arruolamento	15 partecipanti ricercati

Sponsor e collaboratori

CroiValve Limited Sponsor

Bracci e interventi

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

Interventi

Dispositivo DUO Transcatheter Tricuspid Coaptation Valve System
Reduction of tricuspid regurgitation through a transcatheter approach

Esiti misurati

Esito primario
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
Orizzonte temporale At 30 days

Date

Date
Data di inizio	13 agosto 2024 (effettiva)
Conclusione primaria	1 dicembre 2027 (stimata)
Conclusione	1 ottobre 2029 (stimata)
Prima pubblicazione	22 giugno 2023 (effettiva)
Ultimo aggiornamento	1 giugno 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	maggio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

14 centri stanno reclutando

Poland

Poland
Struttura	Città	Stato o regione	Stato
Medical University of Silesia	Katowice		In reclutamento
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu	Poznan	Poznan	In reclutamento
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym	Warsaw	Warsaw	In reclutamento

United States

United States
Struttura	Città	Stato o regione	Stato
Piedmont Heart Institute	Atlanta	Georgia	In reclutamento
Northwestern University	Chicago	Illinois	In reclutamento
OhioHealth Research Institute	Columbus	Ohio	In reclutamento
UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania	In reclutamento
Allina Health Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	In reclutamento
Columbia University Medical Center/NYPH	New York	New York	In reclutamento
Dignity Health St. Joseph's Hospital & Medical Center	Phoenix	Arizona	In reclutamento
Intermountain Health	Salt Lake City	Utah	In reclutamento
San Antonio Methodist	San Antonio	Texas	Non indicato
University of Washington	Seattle	Washington	In reclutamento
Los Robles Hospital & Medical Center	Thousand Oaks	California	In reclutamento
Ascension Via Christi Research	Wichita	Kansas	In reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

Registro: ClinicalTrials.gov · NCT########

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