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NCT06455787ClinicalTrials.gov

J-Valve Transfemoral Pivotal Study

J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

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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…

Interventionell194 Teilnehmende gesucht40 Studienzentren5 Länder

Kategorien

Herz-Kreislauf100%

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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.

Zusammenfassung

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.

Erkrankungen

  • Aortic Valve Regurgitation
  • Aortic Valve Disease Mixed

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhaseNicht zutreffend
ZuteilungNicht zutreffend
InterventionsmodellSINGLE_GROUP
Primäres ZielTREATMENT
VerblindungNONE (0)
Teilnahme194 Teilnehmende gesucht

Sponsor und Mitwirkende

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

Studienarme und Interventionen

  • J-Valve Transfemoral (TF) SystemEXPERIMENTAL

Interventionen

  • Medizinprodukt 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.

Endpunkte

  1. Primärer Endpunkt

    All-cause mortality at 1 year

    Zeitrahmen 1-year post-procedure

  2. Primärer Endpunkt

    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

    Zeitrahmen 30-days post-procedure

  3. Sekundärer Endpunkt

    Rate of improvement in cardiovascular-specific health status

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

    Zeitrahmen Baseline to 1-year follow-up

  4. Sekundärer Endpunkt

    Improvement in left ventricular end diastolic diameter index (LVEDDi)

    To measure LV remodeling

    Zeitrahmen Baseline to 1-year follow-up

  5. Sekundärer Endpunkt

    Improvement in left ventricular end diastolic volume index (LVEDVi)

    To measure LV remodeling

    Zeitrahmen Baseline to 1-year follow-up

  6. Sekundärer Endpunkt

    Improvement in effective stroke volume index (ESVi)

    To measure LV remodeling

    Zeitrahmen Baseline to 1-year follow-up

  7. Sekundärer Endpunkt

    Improvement in effective cardiac output index (ECOi)

    To measure LV remodeling

    Zeitrahmen Baseline to 1-year follow-up

Daten

Startdatum17. Oktober 2024 (tatsächlich)
Primärer Abschluss1. Februar 2028 (geschätzt)
Abschluss1. Februar 2032 (geschätzt)
Erstveröffentlichung12. Juni 2024 (tatsächlich)
Zuletzt aktualisiert4. Mai 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtAugust 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

40 Studienzentren rekrutieren

Canada

EinrichtungStadtBundesland oder RegionStatus
St. Michael's HospitalTorontoOntarioRekrutiert
St. Paul's Hospital VancouverVancouverBritish ColumbiaRekrutiert

France

EinrichtungStadtBundesland oder RegionStatus
Clinique Pasteur ToulouseToulouseRekrutiert

Japan

EinrichtungStadtBundesland oder RegionStatus
Juntendo University HospitalTokyoBunkyo-kuRekrutiert
Keio University HospitalTokyoShinjuku-KuRekrutiert

United Kingdom

EinrichtungStadtBundesland oder RegionStatus
Oxford - John Radcliff HospitalOxfordRekrutiert

United States

EinrichtungStadtBundesland oder RegionStatus
PiedmontAtlantaGeorgiaRekrutiert
Emory University AtlantaAtlantaGeorgiaRekrutiert
Brigham and Women's HospitalBostonMassachusettsRekrutiert
Massachusetts General Hospital BostonBostonMassachusettsRekrutiert
University at Buffalo - Kaleida HealthBuffaloNew YorkRekrutiert
Carolinas Health System (Atrium)CharlotteNorth CarolinaRekrutiert
Northwestern University ChicagoChicagoIllinoisRekrutiert
The Christ Hospital and The Carl & Edyth Lindner Center for Research and EducationCincinnatiOhioRekrutiert
Henry Ford Hospital DetroitDetroitMichiganRekrutiert
Glenbrook - Endeavor HealthGlenviewIllinoisRekrutiert
Cardiovascular Institute of the SouthHoumaLouisianaRekrutiert
HCA Houston Healthcare Medical CenterHoustonTexasRekrutiert
Houston Methodist HospitalHoustonTexasRekrutiert
Scripps Memorial Hospital La JollaLa JollaCaliforniaRekrutiert
Cedars SinaiLos AngelesCaliforniaRekrutiert
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoRekrutiert
Minneapolis Heart Institute FoundationMinneapolisMinnesotaRekrutiert
NCH Rooney Heart InstituteNaplesFloridaRekrutiert
Ascension St. Thomas West HospitalNashvilleTennesseeRekrutiert
Vanderbilt University Medical CenterNashvilleTennesseeRekrutiert
Columbia University Irving Medical Center/New York-Presbyterian HospitalNew YorkNew YorkRekrutiert
Stanford University Medical CenterPalo AltoCaliforniaRekrutiert
The Heart Hospital - Baylor PlanoPlanoTexasRekrutiert
Oregon Health & Science UniversityPortlandOregonRekrutiert
St. Francis HospitalRoslynNew YorkRekrutiert
CentraCare Heart and Vascular CenterSaint CloudMinnesotaRekrutiert
University of California San FranciscoSan FranciscoCaliforniaRekrutiert
Bay Area Structural Heart at Sutter HealthSan FranciscoCaliforniaRekrutiert
HonorHealth Research & Innovation InstituteScottsdaleArizonaRekrutiert
Swedish Heart & Vascular ResearchSeattleWashingtonRekrutiert
Washington University - Barnes-Jewish Hospital St. LouisSt LouisMissouriRekrutiert
Montefiore Medical CenterThe BronxNew YorkRekrutiert
Washington Hospital Center DCWashington D.C.District of ColumbiaRekrutiert
Ascension Via ChristiWichitaKansasRekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

Register: ClinicalTrials.gov · NCT########

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