Giving LVAD patients with
AR another option.

Transcatheter aortic valve replacement (TAVR) using the JenaValve
Trilogy® Heart Valve System for clinically significant aortic regurgitation (AR)
in patients with left ventricular assist devices (LVAD)

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Objective and Study Population

JENA-VAD is the first prospective, multi-center clinical registry to evaluate the safety and effectiveness of the JenaValve Trilogy Heart Valve System for TAVR in TAVR-indicated patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant AR.

Trilogy valve in patient with LVAD under fluoroscopy
Trilogy valve in patient with LVAD
under fluoroscopy
Meeting the Unmet Need

A high-risk population without a
dedicated TAVR solution.

Up to 30%
Up to 30% of LVAD patients develop moderate to severe AR within the first year, making a difficult condition even more challenging.1

Severe AR in patients with advanced heart failure and LVAD results in recirculation of regurgitant blood volume, for which there is currently no dedicated TAVR solution.

WHY THIS REGISTRY MATTERS

The JENA-VAD registry’s growing body of
clinical evidence opens a new way forward.

01
THE POPULATION
High mortality with surgical AVR.
LVAD patients with significant AR face elevated mortality risk when treated with surgical aortic valve replacement, leaving the heart team with limited options.
02
THE GAP
No dedicated TAVR solution.
There is currently no commercially available TAVR therapy designed for the unique anatomy and physiology of LVAD-supported patients with AR.
03
THE OPPORTUNITY
Early evidence is promising.
Initial reports using AR-dedicated TAVR in this population are encouraging—JENA-VAD will generate the prospective evidence to evaluate safety and feasibility.
Trilogy valve in patient with LVAD under fluoroscopy
Trilogy valve in patient with LVAD under fluoroscopy
Image courtesy of Ravi Ramana, DO. Used with permission.
STUDY AT A GLANCE

What JENA-VAD studies.

Real-world clinical outcomes in patients who receive the Trilogy Heart Valve
System for the treatment of aortic regurgitation while supported by a cfLVAD.
Single-arm
Prospective, non-randomized registry
Up to 50
Patients enrolled across U.S. sites
POPULATION
cfLVAD patients with clinically significant AR
INTERVENTION
TAVR with the JenaValve Trilogy Heart Valve System
Sites
Experienced sites from the ALIGN-AR trial with high-volume Trilogy experience
GEOGRAPHY
United States
ELIGIBILITY

Who Is eligible for the registry?

REGISTRY INCLUSION CRITERIA
Subjects must meet all of the following:

Complete inclusion and exclusion criteria are maintained in the registry protocol.

  • Adults (>18) with a continuous flow LVAD with clinically significant AR
  • NYHA functional class III or IV
  • Judged at high or greater surgical risk by a multidisciplinary Heart Team
  • Aortic anatomy suitable for the Trilogy device per protocol-defined dimensions
WHAT JENA-VAD MEASURES

Primary outcomes through 1-year follow-up.

30-day primary efficacy
All-cause mortality
Procedural success
Prosthetic valve performance
Safety endpoints
Death
Stroke
Major bleeding / vascular complications
Acute kidney injury
Need for re-intervention
New permanent pacemaker
Moderate or severe aortic regurgitation
Follow-up visits
30 days
3 months
6 months
1 year

For more information

For inquiries about the JENA-VAD trial
jena-vad@jenavalve.com
For clinical or scientific inquiries
medsci@jenavalve.com
For investigator-initiated study inquiries
iis@jenavalve.com

References

1. Goncharov A, et al. EUR Heart J Case Rep. 2023;7:1-6.

POTENTIAL RISKS

Adverse events that may be anticipated in this clinical registry are believed to be consistent with those associated with other minimally invasive surgical and catheter-based procedures, including TAVR procedures. Complications may occur at any time during the procedure, post-procedure or follow-up period.

Potential adverse events (AE) which may be associated with the ancillary procedures including cardiac catheterization, aortic balloon valvuloplasty and local and/or general anaesthesia include but are not limited to the following: vascular damage (e.g. perforation, dissection, contrast media extravasation), vascular access (femoral entry site) complications (e.g. bleeding, hematoma, arteriovenous fistula, arterial occlusion, pseudo aneurysm, wound healing disorder, pain), peripheral nerve injury and/or ischemia, cardiovascular injury (e.g. damage of ventricle, ventricular septal perforation, myocardium or valvular structures including annulus rupture), hypotension, hypertension, cardiogenic tamponade or pericardial effusion, arrhythmias and conduction system disorders (e.g. ventricular tachycardia or fibrillation; AV block) which may require permanent pacemaker implantation, heart murmur, hemodynamic compromise or cardiogenic shock, heart failure or low cardiac output, cardiac arrest, angina pectoris, myocardial infarction, thrombus formation, embolization (e.g. air, calcific material, thrombus), cerebrovascular event (e.g. TIA, stroke, neurologic changes), pulmonary embolism, pulmonary edema, pleural effusion, respiratory compromise or respiratory failure, renal compromise or renal failure, allergic reaction/hypersensitivity to contrast media, medication, or device materials, inflammation, infection (e.g. endocarditis, access site infection) and sepsis, fever, pneumonia, hemorrhage or bleeding, possibly requiring intervention or transfusion, retroperitoneal bleeding, restenosis, syncope, anemia, abnormal laboratory values (e.g. electrolyte imbalance), exercise intolerance or weakness, paralysis, permanent disability, or other comorbid condition (new onset or worsening) or death.

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The information in this Reimbursement Guide is provided for educational purposes only and is not intended to be coding or billing advice. This coding information is based upon publicly available information and is current as of April 1, 2026 and subject to change without notice. JenaValve Technology, Inc. cannot guarantee that any product or service billed with the codes listed will be covered or, if covered, the listed payment amount will be paid by any payer. It is the responsibility of the provider to select appropriate codes for each patient and to submit appropriate codes, charges, and modifiers for services rendered. Providers should contact insurers to verify correct coding procedures prior to submitting claims related to the use of JenaValve products. In all cases, providers must bill according to the rules, policies and procedures of individual payers. The medical record should document that the product or procedure was medically necessary and furnished or performed as reported. Clinical need, not reimbursement amount, should always drive clinical decision making. If you have any questions about appropriate billing for products or services, please consult your local payer. The information contained in this guide is provided to assist providers in understanding the reimbursement process. It is intended to assist providers in obtaining accurate and appropriate reimbursement for the healthcare services provided. It is not intended to increase or maximize reimbursement by any payer. It is strongly recommended that providers consult with their payer organizations with regard to local reimbursement policies. The information contained herein is provided for information purposes only and represents no statement, promise, or guarantee by JenaValve Technology, Inc. concerning levels of reimbursement, payment, or charge. Similarly, all CPT codes are supplied for information purposes only and represent no statement, promise, or guarantee by JenaValve Technology, Inc. that these codes will be appropriate or that reimbursement will be made. For additional information, please contact us at reimbursement.usa@jenavalve.com.