The JenaValve ALIGN-AR LVAD Registry (JENA-VAD)

Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease; Aortic Regurgitation; Aortic Valve Insufficiency; Left Ventricular Dysfunction; Aortic Insufficiency
• Intervention / Treatment: Device: JenaValve Trilogy Heart Valve System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Duane Pinto; Phone Number: 949-767-2110; Email: pinto@jenavalve.com
• Study Contact Backup: Name: David Haan; Phone Number: 949-767-2110; Email: haan@jenavalve.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
    • San Francisco, California, United States, 94109
      • Recruiting
      • Sutter Health
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Medstar Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • Advocate Christ Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University, St. Louis
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center/New York-Presbyterian Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Research Center
    • Plano, Texas, United States, 75024
      • Recruiting
      • Baylor
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 assessed clinically and, if available, by baseline right heart catheterization hemodynamics (e.g., right atrial pressure > pulmonary capillary wedge pressure and cardiac index < 2.5 L/min/m2
10. Severe RV dysfunction as assessed clinically and by echocardiography
11. Aortic annular diameter of <21.0 mm or > 28.6 mm (assessed by Multi-detector CT measurement)
12. Aortic annulus angulation > 70° (assessed by Multi-detector CT measurement)
13. Straight length of ascending aorta of < 55 mm
14. 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)
15. Myocardial infarction < 30 days prior to index procedure
16. Cerebrovascular event (TIA, stroke) < 180 days prior to index procedure
17. 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)
18. Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to index procedure
19. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated
20. Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing
21. Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this registry)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVR in LVAD Patients; Transcatheter Aortic Valve Replacement (TAVR) TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR)	Device: JenaValve Trilogy Heart Valve System; TAVR with JenaValve Trilogy Heart Valve System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: JenaValve Technology, Inc.
• Investigators: Principal Investigator: Vinod Thourani, MD, Piedmont Heart Institute; Study Chair: Nir Uriel, MD, Columbia University; Principal Investigator: Gabriel Sayer, MD, Columbia University; Principal Investigator: Ravi Ramana, DO, Advocate Christ Medical Center

Publications and helpful links

Helpful Links

• Uriel N, Sayer G, Addetia K, et al. Hemodynamic Ramp Tests in Patients With Left Ventricular Assist Devices. JACC Heart Fail 2016; 4(3): 208-17.
• Stainback RF, Estep JD, Agler DA, et al. Echocardiography in the Management of Patients with Left Ventricular Assist Devices: Recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr 2015; 28(8): 853-909.
• Accurate Quantification Methods for Aortic Insufficiency Severity in Patients With LVAD: Role of Diastolic Flow Acceleration and Systolic-to-Diastolic Peak Velocity Ratio of Outflow Cannula

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Dysfunction; Aortic Valve Disease; Ventricular Dysfunction, Left; Aortic Valve Insufficiency
• Other Study ID Numbers: JVT24002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No