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NCT06455787ClinicalTrials.gov

J-Valve Transfemoral Pivotal Study

J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

En recrutementAccepte des participants actuellement, selon la fiche du registre.
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En bref

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…

Interventionnelle194 participants recherchés40 sites5 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Aortic Valve Regurgitation
  • Aortic Valve Disease Mixed

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhaseSans objet
RépartitionSans objet
Modèle d'interventionSINGLE_GROUP
Objectif principalTREATMENT
InsuNONE (0)
Recrutement194 participants recherchés

Promoteur et collaborateurs

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

Groupes et interventions

  • J-Valve Transfemoral (TF) SystemEXPERIMENTAL

Interventions

  • Dispositif 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.

Critères de jugement

  1. Critère de jugement principal

    All-cause mortality at 1 year

    Délai 1-year post-procedure

  2. Critère de jugement 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

    Délai 30-days post-procedure

  3. Critère de jugement secondaire

    Rate of improvement in cardiovascular-specific health status

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

    Délai Baseline to 1-year follow-up

  4. Critère de jugement secondaire

    Improvement in left ventricular end diastolic diameter index (LVEDDi)

    To measure LV remodeling

    Délai Baseline to 1-year follow-up

  5. Critère de jugement secondaire

    Improvement in left ventricular end diastolic volume index (LVEDVi)

    To measure LV remodeling

    Délai Baseline to 1-year follow-up

  6. Critère de jugement secondaire

    Improvement in effective stroke volume index (ESVi)

    To measure LV remodeling

    Délai Baseline to 1-year follow-up

  7. Critère de jugement secondaire

    Improvement in effective cardiac output index (ECOi)

    To measure LV remodeling

    Délai Baseline to 1-year follow-up

Dates

Date de début17 octobre 2024 (réelle)
Achèvement principal1 février 2028 (estimée)
Achèvement1 février 2032 (estimée)
Première publication12 juin 2024 (réelle)
Dernière mise à jour4 mai 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2025

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

40 sites sont en recrutement

Canada

ÉtablissementVilleÉtat ou régionStatut
St. Michael's HospitalTorontoOntarioEn recrutement
St. Paul's Hospital VancouverVancouverBritish ColumbiaEn recrutement

France

ÉtablissementVilleÉtat ou régionStatut
Clinique Pasteur ToulouseToulouseEn recrutement

Japan

ÉtablissementVilleÉtat ou régionStatut
Juntendo University HospitalTokyoBunkyo-kuEn recrutement
Keio University HospitalTokyoShinjuku-KuEn recrutement

United Kingdom

ÉtablissementVilleÉtat ou régionStatut
Oxford - John Radcliff HospitalOxfordEn recrutement

United States

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

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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