ACTIVE_NOT_RECRUITING

J-Valve Transfemoral Pivotal Study

Conditions

Aortic Valve Regurgitation Aortic Valve Disease Mixed J-Valve Transfemoral System Transcatheter Therapy Transcatheter Aortic Valve Replacement TAVR Transfemoral

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

Quick Facts

Study Start:2024-10-17

Study Completion:2031-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06455787

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 3. Patient is judged by a multi-disciplinary heart team to be at high risk for surgery 4. Patient has suitable anatomy to accommodate the insertion, delivery, and deployment of the study valve system 5. Patient or the patient's legal representative has provided written informed consent and agrees to comply with all required post-procedure follow-up visits at investigational site.	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 including cirrhosis (Childs-Pugh Class B or C) 10. Blood dyscrasias as defined: leukopenia (WBC \<3000 mm\^3), thrombocytopenia (platelet count \<50,000 cells/mm\^3), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis or coagulopathy 11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) 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 3 months 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. Subject considered to be part of a vulnerable population 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 ≥4.0 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

Inclusion Criteria

Exclusion 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:
3. Patient is judged by a multi-disciplinary heart team to be at high risk for surgery
4. Patient has suitable anatomy to accommodate the insertion, delivery, and deployment of the study valve system
5. Patient or the patient's legal representative has provided written informed consent and agrees to comply with all required post-procedure follow-up visits at investigational site.

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 including cirrhosis (Childs-Pugh Class B or C)
10. Blood dyscrasias as defined: leukopenia (WBC \<3000 mm\^3), thrombocytopenia (platelet count \<50,000 cells/mm\^3), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis or coagulopathy
11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) 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 3 months 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. Subject considered to be part of a vulnerable population
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 ≥4.0 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

Contacts and Locations

Principal Investigator

Dean J Kereiakes, MD

STUDY_CHAIR

The Christ Hospital Heart & Vascular Institute

Michael Reardon, MD

STUDY_CHAIR

The Methodist Hospital Research Institute

Santiago Garcia, MD

PRINCIPAL_INVESTIGATOR

The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education

Tsuyoshi Kaneko, MD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

HonorHealth Research & Innovation Institute

Scottsdale, Arizona, 85258

United States

Cedars Sinai

Los Angeles, California, 90048

United States

NCH Rooney Heart Institute

Naples, Florida, 34102

United States

Ascension Via Christi

Wichita, Kansas, 67214

United States

Cardiovascular Institute of the South

Houma, Louisiana, 70360

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219

United States

Ascension St. Thomas West Hospital

Nashville, Tennessee, 37205

United States

Swedish Heart & Vascular Research

Seattle, Washington, 98122

United States

Collaborators and Investigators

Sponsor: JC Medical, Inc.

Dean J Kereiakes, MD, STUDY_CHAIR, The Christ Hospital Heart & Vascular Institute
Michael Reardon, MD, STUDY_CHAIR, The Methodist Hospital Research Institute
Santiago Garcia, MD, PRINCIPAL_INVESTIGATOR, The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education
Tsuyoshi Kaneko, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17

Study Completion Date2031-12

Study Record Updates

Study Start Date2024-10-17

Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

J-Valve Transfemoral System
Transcatheter Therapy
Transcatheter Aortic Valve Replacement
TAVR
Transfemoral

Additional Relevant MeSH Terms

Aortic Valve Regurgitation
Aortic Valve Disease Mixed