Aortic Valve Regurgitation Clinical Trial
— JOURNEYOfficial title:
J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy
NCT number | NCT06455787 |
Other study ID # | JCM-002 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2024 |
Est. completion date | July 2030 |
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).
Status | Not yet recruiting |
Enrollment | 171 |
Est. completion date | July 2030 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher; 2. Severe AR, defined as follows (Either A or B): A. Severe AR by Echocardiography (grade 3 or 4) B. Indeterminate AR, in addition to 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; 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 and delivery of the J-Valve TF System; 5. Patient or the patient's legal representative has provided written informed consent; 6. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits. 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. Active gastrointestinal (GI) bleeding that would preclude anticoagulation; 7. Renal insufficiency (eGFR <25 ml/min/1.73m^2) or end stage renal disease requiring chronic dialysis; 8. Liver failure (Childs-Pugh Class C); 9. Blood dyscrasias as defined: leukopenia (WBC <1000 mm^3), thrombocytopenia (platelet count <50,000 cells/mm^3), history of bleeding diathesis or coagulopathy; 10. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to contrast media, which cannot be adequately premedicated; 11. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram (or by CMR, when performed); 12. Untreated multivessel coronary artery disease with a SYNTAX score >22 or unprotected left main coronary artery disease = 50% 13. Acute myocardial infarction within 30 days prior to index procedure; 14. PCI within 30 days prior to index procedure; 15. Carotid intervention within 6 weeks prior to index procedure; 16. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure; 17. Uncontrolled atrial fibrillation (e.g., resting heart rate >120 bpm); 18. Severe right ventricular (RV) dysfunction; 19. Pulmonary hypertension (systolic PA pressure >70mmHg or systolic PA pressure =2/3 of systemic systolic BP); 20. Severe chronic obstructive pulmonary disease (COPD) = requiring steroids or requiring continuous home O2; 21. Carotid disease requiring intervention; 22. Anticipated coronary revascularization procedure within 12 months post index procedure; 23. Stroke (CVA) or transient ischemic attack (TIA) within 6 months prior to index procedure; 24. 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; 25. Patient requires mechanical circulatory support; 26. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions; 27. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements; 28. Participation in another investigational study. Anatomic Exclusions: 1. Ascending Aortic diameter >5 cm; 2. Aortic Annulus Perimeter <57 mm or >104 mm; 3. Access vessel minimum diameter <5.5 mm for 18F delivery system and <6.0 for 21F delivery 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. Significant aortic valve prolapse; 8. Abdominal 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 >80°. In most cases, this exclusion will be identified and assigned following review by the multi-disciplinary Study Screening Committee. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
JC Medical, Inc. | Bright Research Partners, Cardiovascular Research Foundation, New York, Minneapolis Heart Institute Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of all-cause mortality at 1 year | 1-year post-procedure | ||
Primary | 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. |
30-days post-procedure | |
Secondary | Rate of improvement in cardiovascular-specific health status | As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) | Baseline to 1-year follow-up | |
Secondary | Rate of the individual components of the composite early-safety endpoint at 30 days | Includes:
All-cause death; All stroke; VARC-3 type 2-4 bleeding; Major vascular, access-related, or cardiac structuralcomplication Acute kidney injury (AKI) stage 3 or 4; New permanent pacemaker due to procedure-relatedconduction abnormalities; Surgery or intervention related to the device. |
30-days post-procedure |
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