The JenaValve ALIGN-AR LVAD Registry

Launched by JENAVALVE TECHNOLOGY, INC. · Sep 10, 2024

Keywords

ClinConnect Summary

The JenaValve ALIGN-AR LVAD Registry is a clinical trial designed to test a new heart valve system called the JenaValve Trilogy™. This trial focuses on patients who have a specific heart condition known as aortic regurgitation (AR), which means the aortic valve isn't working properly and is causing problems for those using a continuous flow left ventricular assist device (cfLVAD). The goal is to see if this new heart valve can safely and effectively help improve the health of these patients who are at high risk for more invasive surgeries.

To participate in this trial, individuals must be at least 18 years old and currently using a cfLVAD due to significant AR that affects their heart function. They should be experiencing severe symptoms that limit their daily activities and have a medical team that agrees they are at high risk for traditional heart surgery. Participants will need to provide consent and attend follow-up visits after receiving the new heart valve to monitor their progress. It’s important to note that certain conditions, like severe heart dysfunction or other serious health issues, may prevent someone from participating in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Subjects \>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:
• • • AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1
• • 2. Patient with NYHA functional class III/IV
• • 3. Patient with high risk for SAVR as documented by Heart Team.
• • 4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve 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. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
• • 2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• • 3. Mitral regurgitation \> moderate
• • 4. Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure
• • 5. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
• • 6. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
• • 7. Hypertrophic cardiomyopathy with or without obstruction
• • 8. Severe pulmonary hypertension (systolic PA pressure \>80 mmHg)
• • 9. Decompensated right heart failure as based on baseline right heart catheterization findings: right atrial pressure \> pulmonary capillary wedge pressure and cardiac index \< 2.5 ml/L/m2
• • 10. Severe RV dysfunction as assessed clinically and by echo
• • 11. Aortic annular diameter of \<21.0 mm or \> 28.6 mm (assessed by Multi-detector CT measurement)
• • 12. Chronic Kidney Disease Stage 4 or 5 (\<30 cc/min/1.73 m2 or dialysis)
• • 13. Aortic annulus angulation \> 70° (assessed by Multi-detector CT measurement)
• • 14. Straight length of ascending aorta of \< 55 mm
• • 15. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \[\>5 mm\], protruding or ulcerated)
• • 16. Need for urgent or emergent TAVR procedure for any reason
• • 17. Myocardial infarction \< 30 days prior to index procedure
• • 18. Cerebrovascular event (TIA, stroke) \< 180 days prior to index procedure
• • 19. Blood dyscrasias as defined: leukopenia (WBC \< 3000/mm³), or thrombocytopenia (platelets \< 90,000/μl) or anemia (Men: Hgb \< 8.1 g/dl; Women: Hgb \< 7.4 g/dl)
• • 20. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to index procedure
• • 21. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated