Aortic RegurgitationJENA-VADNCT06594705
The JenaValve ALIGN-AR LVAD Registry
A study testing JenaValve Trilogy Heart Valve System in people with Aortic Regurgitation and Aortic Valve Insufficiency, run by JenaValve Technology, Inc. at 14 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- What is being tested?
- JenaValve Trilogy Heart Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 14 sitesUnited States
- Study dates
- 9 Dec 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Cerebrovascular event (TIA, stroke) < 180 days prior to index procedure
- 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)
- Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to index procedure
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated
- Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing
- 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)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont
Atlanta, Georgia, 30309
Henry Ford Hospital
Detroit, Michigan, 48202
Houston Methodist Research Center
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Intermountain
Murray, Utah, 84107
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, 10032
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Baylor
Plano, Texas, 75024
Sutter Health
San Francisco, California, 94109
Washington University, St. Louis
St Louis, Missouri, 63130
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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)
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
- Being tested
- JenaValve Trilogy Heart Valve System
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Disease, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JenaValve Trilogy Heart Valve SystemDevice
TAVR with JenaValve Trilogy Heart Valve System
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: JenaValve Trilogy Heart Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Modified VARC-3 Device Success
Device Success Modified for the LVAD Population
Measured: 30 days
Primary Safety Endpoint: VARC-3 Early Safety Composite
Safety Composite Endpoint According to VARC-3 Criteria
Measured: 30 days
Secondary outcomes (10)
Technical Success
Technical Success According to VARC-3 Definition
Measured: At Exit From Procedure Room
Device Performance
Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)*
Measured: 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
Measured: 30 days and 1 year
Bleeding
Freedom from VARC type 2-4 bleeding
Measured: 30 days and 1 year
All Stroke
Number of patients that had stroke
Measured: 30 days and 1 year
Acute Kidney Injury
Number of patients that had acute kidney injury (AKI) stage 3 or 4
Measured: 7 days
Total aortic regurgitation
Number of patients that had moderate or severe total aortic regurgitation
Measured: 30 days and 1 year
Major Vascular Complication
Number of patients that had major vascular, access-related, or cardiac structural complication
Measured: 30 days and 1 year
Permanent pacemaker implantation
Number of patients that had these events
Measured: 30 days
All-cause mortality
All-cause mortality
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- JenaValve Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nir Uriel, MD, Study chair, Columbia UniversityVinod Thourani, MD, Principal investigator, Piedmont Heart InstituteRavi Ramana, DO, Principal investigator, advocate christ medical centerGabriel Sayer, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594705
- Sponsor's protocol ID
- JVT24002
- Acronym
- JENA-VAD
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06594705
- Acronym / sponsor ID
- JENA-VAD / JVT24002
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease, Left Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- JenaValve Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR in LVAD Patients | Experimental | Device: JenaValve Trilogy Heart Valve SystemTranscatheter Aortic Valve Replacement (TAVR) TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects \&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:
- 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
Key exclusion criteria (21 listed)
- Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Mitral regurgitation \&gt; 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JenaValve Trilogy Heart Valve SystemTAVR with JenaValve Trilogy Heart Valve System | Device | TAVR in LVAD Patients |
Primary outcome
Primary Efficacy Endpoint: Modified VARC-3 Device Success
Time frame: 30 days
Device Success Modified for the LVAD Population
Primary Safety Endpoint: VARC-3 Early Safety Composite
Time frame: 30 days
Safety Composite Endpoint According to VARC-3 Criteria
10 secondary outcomes
Technical Success
Time frame: At Exit From Procedure Room
Device Performance
Time frame: 30 days and 1 year
Surgery/intervention related to device
Time frame: 30 days and 1 year
Bleeding
Time frame: 30 days and 1 year
All Stroke
Time frame: 30 days and 1 year
Acute Kidney Injury
Time frame: 7 days
Total aortic regurgitation
Time frame: 30 days and 1 year
Major Vascular Complication
Time frame: 30 days and 1 year
Permanent pacemaker implantation
Time frame: 30 days
All-cause mortality
Time frame: 30 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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 CannulaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Uriel, MD study chair
Columbia University
Vinod Thourani, MD principal investigator
Piedmont Heart Institute
Ravi Ramana, DO principal investigator
advocate christ medical center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JenaValve Trilogy Heart Valve System in people with Aortic Regurgitation and Aortic Valve Insufficiency, run by JenaValve Technology, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Modified VARC-3 Device Success (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.