The JenaValve ALIGN-AR LVAD Registry

Not Applicable

Not yet recruiting

• Conditions: Aortic Regurgitation; Aortic Valve Insufficiency; Aortic Insufficiency; Aortic Valve Disease; Left Ventricular Dysfunction
• Interventions: Device: JenaValve Trilogy Heart Valve System

• Registration Number: NCT06594705
• Lead Sponsor: JenaValve Technology, Inc.

Brief Summary

To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVR in LVAD Patients	JenaValve Trilogy Heart Valve System	Transcatheter Aortic Valve Replacement (TAVR) TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR)

Primary Outcome Measures

Name	Time	Method
Device Success	30 days	Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
All Stroke	30 days	Number of patients that had stroke
Acute Kidney Injury	30 days	Number of patients that had acute kidney injury (AKI) stage 3 or 4
Total aortic regurgitation	30 days	Number of patients that had moderate or severe total aortic regurgitation
Device Positioning	30 days	Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
Device Performance	30 days	Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*
Surgery/intervention related to device	30 days	Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication
Bleeding	30 days	Freedom from VARC type 2-4 bleeding
Major Vascular Complication	30 days	Number of patients that had major vascular, access-related, or cardiac structural complication
Permanent pacemaker implantation	30 days	Number of patients that had these events
All-cause mortality	30 days	All-cause mortality within the first 30 days post index procedure

Secondary Outcome Measures

Name	Time	Method
Device Success	30 days and 1 year	Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
Device Positioning	30 days and 1 year	Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
Device Performance	30 days and 1 year	Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*
Surgery/intervention related to device	30 days and 1 year	Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication
Bleeding	30 days and 1 year	Freedom from VARC type 2-4 bleeding
All Stroke	30 days and 1 year	Number of patients that had stroke
Acute Kidney Injury	30 days and 1 year	Number of patients that had acute kidney injury (AKI) stage 3 or 4
Total aortic regurgitation	30 days and 1 year	Number of patients that had moderate or severe total aortic regurgitation
Major Vascular Complication	30 days and 1 year	Number of patients that had major vascular, access-related, or cardiac structural complication
Permanent pacemaker implantation	30 days and 1 year	Number of patients that had these events
All-cause mortality	30 days and 1 year	All-cause mortality within the first 30 days post index procedure

Trial Locations

Locations (1)

Columbia University Medical Center/New York-Presbyterian Hospital; 🇺🇸 New York, New York, United States