RECRUITING

J-Valve Transfemoral Pivotal Study

Talk to us

Conditions

Aortic Valve RegurgitationAortic Valve Disease MixedJ-Valve Transfemoral SystemTranscatheter TherapyTranscatheter Aortic Valve ReplacementTAVRTransfemoral

Quick Navigation

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:2032-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status: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 CriteriaExclusion Criteria
  1. 1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
  2. 2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory:
  3. 3. High risk for surgery as judged by a multi-disciplinary heart team
  4. 4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
  5. 5. Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site.
  1. 1. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
  2. 2. Aortic valve stenosis \> moderate\*
  3. 3. Severe mitral valve or tricuspid valve regurgitation\*
  4. 4. Severe mitral valve or tricuspid valve stenosis\*
  5. 5. Active infection, including infective endocarditis
  6. 6. Cardiac imaging evidence of cardiac mass, thrombus or vegetation
  7. 7. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
  8. 8. Renal insufficiency (eGFR \<30 mL/min/1.73m\^2) or end stage renal disease requiring chronic dialysis
  9. 9. Liver disease (cirrhosis of the liver \[Child-Pugh Class B or C\])
  10. 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. 11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated
  12. 12. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram (or by CMR, when performed)\*
  13. 13. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure
  14. 14. Acute myocardial infarction within 30 days prior to index procedure
  15. 15. PCI within 30 days prior to index procedure
  16. 16. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
  17. 17. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
  18. 18. Uncontrolled atrial fibrillation
  19. 19. Severe right ventricular (RV) dysfunction\*
  20. 20. Pulmonary hypertension (systolic PA pressure \>70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
  21. 21. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
  22. 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. 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. 24. Patient requires mechanical circulatory support within 30 days prior to index procedure
  25. 25. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
  26. 26. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
  27. 27. Participation in another investigational study that has not reached its primary endpoint
  28. 28. Considered to be part of a vulnerable population
  29. * As assessed by Imaging Core Laboratory
  30. 1. Ascending Aortic diameter \>5 cm\*
  31. 2. Aortic Annulus Perimeter \<57 mm or \>104 mm\*
  32. 3. Inappropriate anatomy for femoral introduction and delivery of the study system
  33. 4. Left ventricular end-diastolic diameter (LVEDD) \>75 mm\*
  34. 5. Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy\*
  35. 6. Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
  36. 7. Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
  37. 8. Abdominal/thoracic aortic aneurysm ≥5.0 cm\*
  38. 9. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
  39. 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
  40. * As assessed by Imaging Core Laboratory

Contacts and Locations

Study Contact

Sheri L Halverson, MPH
CONTACT
1-800-424-3278
sheri_halverson@edwards.com

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
Stanford University Medical Center
Palo Alto, California, 94394
United States
Bay Area Structural Heart at Sutter Health
San Francisco, California, 94109
United States
University of California San Francisco
San Francisco, California, 94143
United States
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, 80538
United States
NCH Rooney Heart Institute
Naples, Florida, 34102
United States
Emory University Atlanta
Atlanta, Georgia, 30308
United States
Piedmont
Atlanta, Georgia, 30309
United States
Northwestern University Chicago
Chicago, Illinois, 60611
United States
Glenbrook - Endeavor Health
Glenview, Illinois, 60026
United States
Ascension Via Christi
Wichita, Kansas, 67214
United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360
United States
Massachusetts General Hospital Boston
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Henry Ford Hospital Detroit
Detroit, Michigan, 48202
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
United States
Washington University - Barnes-Jewish Hospital St. Louis
St Louis, Missouri, 63110
United States
University at Buffalo - Kaleida Health
Buffalo, New York, 14203
United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Ascension St. Thomas West Hospital
Nashville, Tennessee, 37205
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
The Heart Hospital - Baylor Plano
Plano, Texas, 75093
United States
Swedish Heart & Vascular Research
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

  • 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 Date2032-02

Study Record Updates

Study Start Date2024-10-17
Study Completion Date2032-02

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