The JenaValve ALIGN-AR LVAD Registry

NCT06594705 | Recruiting DMC FDA Device

• 1 other identifier: JVT24002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 15

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

Conditions

Aortic Regurgitation; Aortic Valve Insufficiency; Aortic Insufficiency; Aortic Valve Disease; Left Ventricular Dysfunction

Outcome Measures

Primary Outcomes (11)

• 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

• Permanent pacemaker implantation

  Number of patients that had these events

  30 days

• All-cause mortality

  All-cause mortality within the first 30 days post index procedure

  30 days

Secondary Outcomes (11)

• Device Success

  30 days and 1 year

• Device Positioning

  30 days and 1 year

• Device Performance

  30 days and 1 year

• Surgery/intervention related to device

  30 days and 1 year

• Bleeding

  30 days and 1 year

Study Arms (1)

TAVR in LVAD Patients

EXPERIMENTAL

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

Interventions

JenaValve Trilogy Heart Valve System DEVICE

TAVR with JenaValve Trilogy Heart Valve System

TAVR in LVAD Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient with NYHA functional class III/IV
• Patient with high risk for SAVR as documented by Heart Team.
• Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
• Patient or the patient's legal representative has provided written informed consent
• Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits

You may not qualify if:

• Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
• Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• Mitral regurgitation \> moderate
• 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
• Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
• Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
• Hypertrophic cardiomyopathy with or without obstruction
• Severe pulmonary hypertension (systolic PA pressure \>80 mmHg)
• 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
• Severe RV dysfunction as assessed clinically and by echocardiography
• Aortic annular diameter of \<21.0 mm or \> 28.6 mm (assessed by Multi-detector CT measurement)
• Aortic annulus angulation \> 70° (assessed by Multi-detector CT measurement)
• Straight length of ascending aorta of \< 55 mm
• 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)
• Myocardial infarction \< 30 days prior to index procedure

Sponsors & Collaborators

• JenaValve Technology, Inc.: lead

Study Sites (15)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Sutter Health

San Francisco, California, 94109, United States

RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont

Atlanta, Georgia, 30309, United States

RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Washington University, St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Houston Methodist Research Center

Houston, Texas, 77030, United States

RECRUITING

Baylor

Plano, Texas, 75024, United States

RECRUITING

Intermountain

Murray, Utah, 84107, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Related 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

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Valve Disease; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Officials

• Nir Uriel, MD

  Columbia University

  STUDY CHAIR

• Vinod Thourani, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

• Ravi Ramana, DO

  advocate christ medical center

  PRINCIPAL INVESTIGATOR

• Gabriel Sayer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Haan

CONTACT

949-767-2110; haan@jenavalve.com

Duane Pinto

CONTACT

949-767-2110; pinto@jenavalve.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)