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

March 30, 2026 updated by: JenaValve Technology, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Permanent pacemaker implantation
Time Frame: 30 days
Number of patients that had these events
30 days
Device Success
Time Frame: 30 days
Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
30 days
Device Positioning
Time Frame: 30 days
Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
30 days
Device Performance
Time Frame: 30 days
Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)*
30 days
Surgery/intervention related to device
Time Frame: 30 days
Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication
30 days
Bleeding
Time Frame: 30 days
Freedom from VARC type 2-4 bleeding
30 days
All Stroke
Time Frame: 30 days
Number of patients that had stroke
30 days
Acute Kidney Injury
Time Frame: 30 days
Number of patients that had acute kidney injury (AKI) stage 3 or 4
30 days
Total aortic regurgitation
Time Frame: 30 days
Number of patients that had moderate or severe total aortic regurgitation
30 days
Major Vascular Complication
Time Frame: 30 days
Number of patients that had major vascular, access-related, or cardiac structural complication
30 days
All-cause mortality
Time Frame: 30 days
All-cause mortality within the first 30 days post index procedure
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: 30 days and 1 year
Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
30 days and 1 year
Device Positioning
Time Frame: 30 days and 1 year
Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
30 days and 1 year
Device Performance
Time Frame: 30 days and 1 year
Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)*
30 days and 1 year
Surgery/intervention related to device
Time Frame: 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
30 days and 1 year
Bleeding
Time Frame: 30 days and 1 year
Freedom from VARC type 2-4 bleeding
30 days and 1 year
All Stroke
Time Frame: 30 days and 1 year
Number of patients that had stroke
30 days and 1 year
Acute Kidney Injury
Time Frame: 30 days and 1 year
Number of patients that had acute kidney injury (AKI) stage 3 or 4
30 days and 1 year
Total aortic regurgitation
Time Frame: 30 days and 1 year
Number of patients that had moderate or severe total aortic regurgitation
30 days and 1 year
Major Vascular Complication
Time Frame: 30 days and 1 year
Number of patients that had major vascular, access-related, or cardiac structural complication
30 days and 1 year
Permanent pacemaker implantation
Time Frame: 30 days and 1 year
Number of patients that had these events
30 days and 1 year
All-cause mortality
Time Frame: 30 days and 1 year
All-cause mortality within the first 30 days post index procedure
30 days and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JenaValve Technology, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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