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NCT06455787ClinicalTrials.gov

J-Valve Transfemoral Pivotal Study

J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

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En resumen

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who…

De intervención194 participantes buscados40 centros5 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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 2024-06-12; recorded start 2024-10-17
  • 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 3 other studies in this databaseCounted from the lead sponsor named in the record (JC Medical, Inc., an affiliate of Edwards Lifesciences LLC)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 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 rigourMODERATE

A moderately rigorous 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 type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 40 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

ScaleSMALL

A small study, international in scope: 194 participants (target), run at 40 sites, across 5 countries.

How this score is built
  • Enrolment22/40

    194 participants (target)

  • Site count19/25

    40 sites

  • Country count7/15

    5 countries

  • Planned duration10/10

    Planned over about 89 months

  • Sponsor scale2/10

    JC Medical, Inc., an affiliate of Edwards Lifesciences LLC has led 4 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.

Resumen

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

This is a prospective, single arm, multi-center, interventional pivotal study that will enroll up to 194 subjects in up to 35 investigational sites, predominantly in the United States and up to 7 in Canada, Europe, and Japan. Of the 194 subjects, the CMR imaging sub-study will include up to 75 subjects with severe AR already confirmed by TTE. Additionally, up to 40 roll-in subjects may be treated to enable clinical experience and exposure to the device while allowing a reasonable learning curve. The subjects will then be followed 5-years post-procedure of the J-Valve TF System.

Afecciones

  • Aortic Valve Regurgitation
  • Aortic Valve Disease Mixed

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher 2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory: A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4) B. OR, if indeterminate AR, by TTE, ANY ONE of the following: i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index \[LVEDVi\]) \>105 mL/m\^2 for men or LVEDVi \>96 mL/m\^2 for women) iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular end systolic volume index (LVESVi) ≥43mL/m\^2; iv. Severe AR by Transesophageal Echocardiography (TEE) (grade 3 or 4) 3. High risk for surgery as judged by a multi-disciplinary heart team 4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below) 5. Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site. Exclusion Criteria: 1. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant 2. Aortic valve stenosis \> moderate\* 3. Severe mitral valve or tricuspid valve regurgitation\* 4. Severe mitral valve or tricuspid valve stenosis\* 5. Active infection, including infective endocarditis 6. Cardiac imaging evidence of cardiac mass, thrombus or vegetation 7. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy 8. Renal insufficiency (eGFR \<30 mL/min/1.73m\^2) or end stage renal disease requiring chronic dialysis 9. Liver disease (cirrhosis of the liver \[Child-Pugh Class B or C\]) 10. Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mcL), thrombocytopenia (platelet count \<50,000 cells/mcL), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis coagulopathy, or hypercoagulable state (unless therapeutically stable) 11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated 12. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram (or by CMR, when performed)\* 13. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure 14. Acute myocardial infarction within 30 days prior to index procedure 15. PCI within 30 days prior to index procedure 16. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention 17. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure 18. Uncontrolled atrial fibrillation 19. Severe right ventricular (RV) dysfunction\* 20. Pulmonary hypertension (systolic PA pressure \>70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP) 21. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2 22. Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure 23. Cardiogenic shock defined as systolic blood pressure \<90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg 24. Patient requires mechanical circulatory support within 30 days prior to index procedure 25. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions 26. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements 27. Participation in another investigational study that has not reached its primary endpoint 28. Considered to be part of a vulnerable population * As assessed by Imaging Core Laboratory Anatomic Exclusions: 1. Ascending Aortic diameter \>5 cm\* 2. Aortic Annulus Perimeter \<57 mm or \>104 mm\* 3. Inappropriate anatomy for femoral introduction and delivery of the study system 4. Left ventricular end-diastolic diameter (LVEDD) \>75 mm\* 5. Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy\* 6. Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk 7. Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus 8. Abdominal/thoracic aortic aneurysm ≥5.0 cm\* 9. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath 10. Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle \>80⁰ 11. Non-native anatomy in aortic zones 0A \& 0B (aortic valve annulus to the distal margin of the right pulmonary artery); 0C (to innominate) only if deemed unfavorable by the Study Screening Committee * As assessed by Imaging Core Laboratory

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseNo aplicable
AsignaciónNo aplicable
Modelo de intervenciónSINGLE_GROUP
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción194 participantes buscados

Patrocinador y colaboradores

  • JC Medical, Inc., an affiliate of Edwards Lifesciences LLC Patrocinador
  • Minneapolis Heart Institute Foundation Colaboradores
  • Cardiovascular Research Foundation, New York Colaboradores

Grupos e intervenciones

  • J-Valve Transfemoral (TF) SystemEXPERIMENTAL

Intervenciones

  • Dispositivo J-Valve Transfemoral (TF) System

    Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.

Variables de resultado

  1. Variable de resultado principal

    All-cause mortality at 1 year

    Plazo 1-year post-procedure

  2. Variable de resultado principal

    The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3)

    Includes: * All-cause death * All stroke * VARC-3 type 2-4 bleeding * Major vascular, access-related, or cardiac structural complication * Acute kidney injury (AKI) stage 3 or 4 * New permanent pacemaker due to procedure-related conduction abnormalities * Surgery or intervention related to the device

    Plazo 30-days post-procedure

  3. Variable de resultado secundaria

    Rate of improvement in cardiovascular-specific health status

    As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS)

    Plazo Baseline to 1-year follow-up

  4. Variable de resultado secundaria

    Improvement in left ventricular end diastolic diameter index (LVEDDi)

    To measure LV remodeling

    Plazo Baseline to 1-year follow-up

  5. Variable de resultado secundaria

    Improvement in left ventricular end diastolic volume index (LVEDVi)

    To measure LV remodeling

    Plazo Baseline to 1-year follow-up

  6. Variable de resultado secundaria

    Improvement in effective stroke volume index (ESVi)

    To measure LV remodeling

    Plazo Baseline to 1-year follow-up

  7. Variable de resultado secundaria

    Improvement in effective cardiac output index (ECOi)

    To measure LV remodeling

    Plazo Baseline to 1-year follow-up

Fechas

Fecha de inicio17 de octubre de 2024 (real)
Finalización principal1 de febrero de 2028 (estimada)
Finalización1 de febrero de 2032 (estimada)
Primera publicación12 de junio de 2024 (real)
Última actualización4 de mayo de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

40 centros están en reclutamiento

Canada

CentroCiudadEstado o regiónEstado
St. Michael's HospitalTorontoOntarioEn reclutamiento
St. Paul's Hospital VancouverVancouverBritish ColumbiaEn reclutamiento

France

CentroCiudadEstado o regiónEstado
Clinique Pasteur ToulouseToulouseEn reclutamiento

Japan

CentroCiudadEstado o regiónEstado
Juntendo University HospitalTokyoBunkyo-kuEn reclutamiento
Keio University HospitalTokyoShinjuku-KuEn reclutamiento

United Kingdom

CentroCiudadEstado o regiónEstado
Oxford - John Radcliff HospitalOxfordEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
PiedmontAtlantaGeorgiaEn reclutamiento
Emory University AtlantaAtlantaGeorgiaEn reclutamiento
Brigham and Women's HospitalBostonMassachusettsEn reclutamiento
Massachusetts General Hospital BostonBostonMassachusettsEn reclutamiento
University at Buffalo - Kaleida HealthBuffaloNew YorkEn reclutamiento
Carolinas Health System (Atrium)CharlotteNorth CarolinaEn reclutamiento
Northwestern University ChicagoChicagoIllinoisEn reclutamiento
The Christ Hospital and The Carl & Edyth Lindner Center for Research and EducationCincinnatiOhioEn reclutamiento
Henry Ford Hospital DetroitDetroitMichiganEn reclutamiento
Glenbrook - Endeavor HealthGlenviewIllinoisEn reclutamiento
Cardiovascular Institute of the SouthHoumaLouisianaEn reclutamiento
HCA Houston Healthcare Medical CenterHoustonTexasEn reclutamiento
Houston Methodist HospitalHoustonTexasEn reclutamiento
Scripps Memorial Hospital La JollaLa JollaCaliforniaEn reclutamiento
Cedars SinaiLos AngelesCaliforniaEn reclutamiento
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoEn reclutamiento
Minneapolis Heart Institute FoundationMinneapolisMinnesotaEn reclutamiento
NCH Rooney Heart InstituteNaplesFloridaEn reclutamiento
Ascension St. Thomas West HospitalNashvilleTennesseeEn reclutamiento
Vanderbilt University Medical CenterNashvilleTennesseeEn reclutamiento
Columbia University Irving Medical Center/New York-Presbyterian HospitalNew YorkNew YorkEn reclutamiento
Stanford University Medical CenterPalo AltoCaliforniaEn reclutamiento
The Heart Hospital - Baylor PlanoPlanoTexasEn reclutamiento
Oregon Health & Science UniversityPortlandOregonEn reclutamiento
St. Francis HospitalRoslynNew YorkEn reclutamiento
CentraCare Heart and Vascular CenterSaint CloudMinnesotaEn reclutamiento
University of California San FranciscoSan FranciscoCaliforniaEn reclutamiento
Bay Area Structural Heart at Sutter HealthSan FranciscoCaliforniaEn reclutamiento
HonorHealth Research & Innovation InstituteScottsdaleArizonaEn reclutamiento
Swedish Heart & Vascular ResearchSeattleWashingtonEn reclutamiento
Washington University - Barnes-Jewish Hospital St. LouisSt LouisMissouriEn reclutamiento
Montefiore Medical CenterThe BronxNew YorkEn reclutamiento
Washington Hospital Center DCWashington D.C.District of ColumbiaEn reclutamiento
Ascension Via ChristiWichitaKansasEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

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

https://xmedica.io/trials/ctgov/NCT06455787