Clinical trial NCT06594705: The JenaValve ALIGN-AR LVAD Registry
Official title: Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients with Left Ventricular Assist Devices (LVAD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Regurgitation
Aortic Valve Insufficiency
Aortic Insufficiency
Aortic Valve Disease
Left Ventricular Dysfunction
Lead sponsor: JenaValve Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Subjects \&amp;gt;=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 \&amp;gt; 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 \&amp;gt;80 mmHg)
9. Decompensated right heart failure as based on baseline right heart catheterization findings: right atrial pressure \&amp;gt; pulmonary capillary wedge pressure and cardiac index \&amp;lt; 2.5 ml/L/m2
10. Severe RV dysfunction as assessed clinically and by echo
11. Aortic annular diameter of \&amp;lt;21.0 mm or \&amp;gt; 28.6 mm (assessed by Multi-detector CT measurement)
12. Chronic Kidney Disease Stage 4 or 5 (\&amp;lt;30 cc/min/1.73 m2 or dialysis)
13. Aortic annulus angulation \&amp;gt; 70° (assessed by Multi-detector CT measurement)
14. Straight length of ascending aorta of \&amp;lt; 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 \[\&amp;gt;5 mm\], protruding or ulcerated)
16. Need for urgent or emergent TAVR procedure for any reason
17. Myocardial infarction \&amp;lt; 30 days prior to index procedure
18. Cerebrovascular event (TIA, stroke) \&amp;lt; 180 days prior to index procedure
19. Blood dyscrasias as defined: leukopenia (WBC \&amp;lt; 3000/mm³), or thrombocytopenia (platelets \&amp;lt; 90,000/μl) or anemia (Men: Hgb \&amp;lt; 8.1 g/dl; Women: Hgb \&amp;lt; 7.4 g/dl)
20. Active peptic ulcer or upper gastrointestinal bleeding \&amp;lt; 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

Primary outcomes:
measure: Device Success
timeFrame: 30 days
measure: Device Positioning
timeFrame: 30 days
measure: Device Performance
timeFrame: 30 days
measure: Surgery/intervention related to device
timeFrame: 30 days
measure: Bleeding
timeFrame: 30 days
measure: All Stroke
timeFrame: 30 days
measure: Acute Kidney Injury
timeFrame: 30 days
measure: Total aortic regurgitation
timeFrame: 30 days
measure: Major Vascular Complication
timeFrame: 30 days
measure: Permanent pacemaker implantation
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: Device Success
timeFrame: 30 days and 1 year
measure: Device Positioning
timeFrame: 30 days and 1 year
measure: Device Performance
timeFrame: 30 days and 1 year
measure: Surgery/intervention related to device
timeFrame: 30 days and 1 year
measure: Bleeding
timeFrame: 30 days and 1 year
measure: All Stroke
timeFrame: 30 days and 1 year
measure: Acute Kidney Injury
timeFrame: 30 days and 1 year
measure: Total aortic regurgitation
timeFrame: 30 days and 1 year
measure: Major Vascular Complication
timeFrame: 30 days and 1 year
measure: Permanent pacemaker implantation
timeFrame: 30 days and 1 year
measure: All-cause mortality
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/New York-Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Nir Uriel, MD
role: STUDY_CHAIR
affiliation: Piedmont Heart Institute
name: Vinod Thourani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: advocate christ medical center
name: Ravi Ramana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Gabriel Sayer, MD
role: PRINCIPAL_INVESTIGATOR
References: