J-Valve Transfemoral Pivotal Study

Aortic Valve Regurgitation Clinical Trial

— JOURNEY  

Official title:

J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455787
• Other study ID #: JCM-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2030

Study information

• Verified date: June 2024
• Source: JC Medical, Inc.
• Contact: Sheri Halverson, MPh
• Phone: 650-477-2781
• Email: shalverson[@]jcmedicalinc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

This is a prospective, single arm, multi-center, interventional pivotal study that will enroll up to 171 subjects in up to 25 investigational sites in the United States and Canada. The subjects will then be followed 5-years post-procedure of the J-Valve TF System.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Disease Mixed
• Aortic Valve Insufficiency
• Aortic Valve Regurgitation

Intervention

Device:
• 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, J-Valve TF Delivery Device, and Loading Accessories, during transcatheter aortic valve replacement (TAVR).

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
JC Medical, Inc.	Bright Research Partners, Cardiovascular Research Foundation, New York, Minneapolis Heart Institute Foundation

Outcome

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

External Links

•   JC Medical, Inc. company website.