NCT06455787ClinicalTrials.gov

J-Valve Transfemoral Pivotal Study

J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

تدخّليةمطلوب 194 مشاركاً40 موقعاً5 دول

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06455787فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

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هل أنت مهتم بهذه الدراسة؟

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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 2024-06-12; recorded start 2024-10-17
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 3 other studies in this databaseCounted from the lead sponsor named in the record (JC Medical, Inc., an affiliate of Edwards Lifesciences LLC)
Not stated: 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.

ملخص

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.

الحالات

Aortic Valve Regurgitation
Aortic Valve Disease Mixed

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	غير منطبق
التخصيص	غير منطبق
نموذج التدخّل	SINGLE_GROUP
الغرض الأساسي	TREATMENT
التعمية	NONE (0)
التجنيد	مطلوب 194 مشاركاً

الجهة الراعية والمتعاونون

JC Medical, Inc., an affiliate of Edwards Lifesciences LLC الجهة الراعية
Minneapolis Heart Institute Foundation المتعاونون
Cardiovascular Research Foundation, New York المتعاونون

الأذرع والتدخلات

J-Valve Transfemoral (TF) SystemEXPERIMENTAL

التدخلات

جهاز 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.

مقاييس النتائج

مقياس النتيجة الأولي
All-cause mortality at 1 year
الإطار الزمني 1-year post-procedure
مقياس النتيجة الأولي
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
الإطار الزمني 30-days post-procedure
مقياس النتيجة الثانوي
Rate of improvement in cardiovascular-specific health status
As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS)
الإطار الزمني Baseline to 1-year follow-up
مقياس النتيجة الثانوي
Improvement in left ventricular end diastolic diameter index (LVEDDi)
To measure LV remodeling
الإطار الزمني Baseline to 1-year follow-up
مقياس النتيجة الثانوي
Improvement in left ventricular end diastolic volume index (LVEDVi)
To measure LV remodeling
الإطار الزمني Baseline to 1-year follow-up
مقياس النتيجة الثانوي
Improvement in effective stroke volume index (ESVi)
To measure LV remodeling
الإطار الزمني Baseline to 1-year follow-up
مقياس النتيجة الثانوي
Improvement in effective cardiac output index (ECOi)
To measure LV remodeling
الإطار الزمني Baseline to 1-year follow-up

التواريخ

التواريخ
تاريخ البدء	17 أكتوبر 2024 (فعلي)
الإتمام الأولي	1 فبراير 2028 (تقديري)
الإتمام	1 فبراير 2032 (تقديري)
أول نشر	12 يونيو 2024 (فعلي)
آخر تحديث	4 مايو 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	أغسطس 2025

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

40 موقعاً قيد التجنيد

Canada

Canada
المنشأة	المدينة	الولاية أو المنطقة	الحالة
St. Michael's Hospital	Toronto	Ontario	قيد التجنيد
St. Paul's Hospital Vancouver	Vancouver	British Columbia	قيد التجنيد

France

France
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Clinique Pasteur Toulouse	Toulouse		قيد التجنيد

Japan

Japan
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Juntendo University Hospital	Tokyo	Bunkyo-ku	قيد التجنيد
Keio University Hospital	Tokyo	Shinjuku-Ku	قيد التجنيد

United Kingdom

United Kingdom
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Oxford - John Radcliff Hospital	Oxford		قيد التجنيد

United States

United States
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Piedmont	Atlanta	Georgia	قيد التجنيد
Emory University Atlanta	Atlanta	Georgia	قيد التجنيد
Brigham and Women's Hospital	Boston	Massachusetts	قيد التجنيد
Massachusetts General Hospital Boston	Boston	Massachusetts	قيد التجنيد
University at Buffalo - Kaleida Health	Buffalo	New York	قيد التجنيد
Carolinas Health System (Atrium)	Charlotte	North Carolina	قيد التجنيد
Northwestern University Chicago	Chicago	Illinois	قيد التجنيد
The Christ Hospital and The Carl & Edyth Lindner Center for Research and Education	Cincinnati	Ohio	قيد التجنيد
Henry Ford Hospital Detroit	Detroit	Michigan	قيد التجنيد
Glenbrook - Endeavor Health	Glenview	Illinois	قيد التجنيد
Cardiovascular Institute of the South	Houma	Louisiana	قيد التجنيد
HCA Houston Healthcare Medical Center	Houston	Texas	قيد التجنيد
Houston Methodist Hospital	Houston	Texas	قيد التجنيد
Scripps Memorial Hospital La Jolla	La Jolla	California	قيد التجنيد
Cedars Sinai	Los Angeles	California	قيد التجنيد
UC Health Northern Colorado (Medical Center of the Rockies)	Loveland	Colorado	قيد التجنيد
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	قيد التجنيد
NCH Rooney Heart Institute	Naples	Florida	قيد التجنيد
Ascension St. Thomas West Hospital	Nashville	Tennessee	قيد التجنيد
Vanderbilt University Medical Center	Nashville	Tennessee	قيد التجنيد
Columbia University Irving Medical Center/New York-Presbyterian Hospital	New York	New York	قيد التجنيد
Stanford University Medical Center	Palo Alto	California	قيد التجنيد
The Heart Hospital - Baylor Plano	Plano	Texas	قيد التجنيد
Oregon Health & Science University	Portland	Oregon	قيد التجنيد
St. Francis Hospital	Roslyn	New York	قيد التجنيد
CentraCare Heart and Vascular Center	Saint Cloud	Minnesota	قيد التجنيد
University of California San Francisco	San Francisco	California	قيد التجنيد
Bay Area Structural Heart at Sutter Health	San Francisco	California	قيد التجنيد
HonorHealth Research & Innovation Institute	Scottsdale	Arizona	قيد التجنيد
Swedish Heart & Vascular Research	Seattle	Washington	قيد التجنيد
Washington University - Barnes-Jewish Hospital St. Louis	St Louis	Missouri	قيد التجنيد
Montefiore Medical Center	The Bronx	New York	قيد التجنيد
Washington Hospital Center DC	Washington D.C.	District of Columbia	قيد التجنيد
Ascension Via Christi	Wichita	Kansas	قيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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