New heart valve procedure could offer a gentler option for leaky valve patients

NCT ID NCT06608823

Disease control Sponsor: JenaValve Technology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This study tests a new, less invasive way to replace a leaky aortic heart valve (aortic regurgitation) using a device called the JenaValve Trilogy, compared to standard open-heart surgery. About 1,000 people with moderate to severe aortic regurgitation will be randomly assigned to get either the new procedure or surgery. Researchers will track deaths, strokes, and unplanned heart-related hospital stays over 12 months to see if the new method is as safe and effective as surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: JenaValve Trilogy transcatheter heart valve system
What this could lead to: If successful, this could offer a less invasive alternative to open-heart surgery for people with a leaky aortic valve, potentially reducing recovery time and hospital stays.
What could go wrong: This is a large trial but still experimental for this specific condition. The new device may not be as durable as surgical valves, and there are risks like stroke or need for rehospitalization.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,016 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Feb 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Clinical indication for AVR for native valve predominant AR defined as: 1. Class I or II indication for AVR according to ACC/AHA or ESC/EACTS guidelines with moderate to severe or severe AR (Grade ≥3+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory OR 2. AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage\* from AR with unanimous agreement from the local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR 2. The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve 3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits 4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements Exclusion Criteria: 1. Confirmed moderate (2+) or less AR severity by core laboratory evaluation 2. Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions 3. Subject is high-risk for SAVR as determined by the local heart team 4. Subject refuses SAVR as a treatment option 5. Subject refuses a blood transfusion 6. Subject is selected for aortic valve repair or aortic surgery 7. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention 8. Subject unable to undergo pre-procedure CT scan analysis for annular sizing 9. Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected. 10. Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated 11. Hostile chest or conditions or complications from a prior surgery that would preclude safe reoperation (i.e., mediastinitis, radiation damage, chest wall abnormalities, adhesion of aorta or internal mammary artery (IMA) to the sternum) 12. Need for emergency surgery or TAVR for any reason 13. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support 14. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks 15. Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization 16. LVEF \&amp;lt;25% according to core laboratory measurement of resting echocardiogram at time of screening 17. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory 18. Severe chronic liver disease (Child-Pugh C) or any active liver disease 19. Chronic Kidney Disease Stage 4 or 5 (\&amp;lt;30 cc/min/1.73 m2 or dialysis) 20. Severe Pulmonary Hypertension (pulmonary arterial systolic pressure * amp;amp;gt;2/3 systemic systolic pressure) 21. Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 * amp;amp;lt;50% predicted or need for chronic supplementary oxygen 22. Blood dyscrasia as defined: leukopenia (WBC \&amp;lt;3,000 Cells/μL), thrombocytopenia (platelet count \&amp;lt;50,000 Cells/μL), or anemia (hemoglobin \&amp;lt;9.0 g/dL) that is uncorrected prior to randomization 23. History of bleeding diathesis or coagulopathy that is not adequately treated 24. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy 25. Any condition considered a contraindication to mechanical circulatory support 26. Uncontrolled atrial fibrillation (i.e., resting heart rate \&amp;gt;120 bpm) 27. Evidence of an acute myocardial infarction ≤30 days before the index AVR 28. Any percutaneous coronary or peripheral interventional procedure performed ≤30 days prior to AVR (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe) 29. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization 30. Prior stroke with residual modified Rankin Score ≥2 31. Stroke or transient ischemic attack (TIA) within 6 months of randomization 32. Body mass index (BMI) \&amp;lt;20 or \&amp;gt;50 kg/m2 33. Currently participating in a cardiovascular investigational drug or device trial and has not yet completed follow-up for the primary endpoint (excluding registries) 34. Severe cognitive decline (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) 35. Other medical, social, or psychological conditions that in the opinion of the investigator preclude the subject from appropriate consent or adherence to the protocol required follow-up exams 36. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements 37. Anatomical exclusion criteria (ANY of the following): 1. Congenital bicuspid, unicuspid or quadricuspid aortic valve verified by echocardiography or CCT core laboratory 2. Native aortic annulus perimeter \&amp;lt;66 mm or \&amp;gt;90 mm per the core laboratory reading of baseline cardiac CT imaging 3. Iliofemoral arteries with vessel characteristics unsuitable for sheath passage (e.g., calcification, tortuosity) as determined by the case review board (CRB) 4. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation) that would preclude safe passage of the delivery system or cannulation and aortotomy for SAVR 5. According to the CRB, a combination of aortic root angulation (angle between the plane of the aortic valve annulus and horizontal plane/vertebrae), sinus size, and straight length of the aorta that will not allow safe device delivery and THV deployment 6. Sinus of Valsalva anatomy that would prevent adequate coronary perfusion after valve implantation 38. According to core laboratory evaluation, severe aortic stenosis 39. Uncorrected hypertrophic obstructive cardiomyopathy 40. Echocardiographic or Multi-slice CT (MSCT) evidence of untreated intracardiac mass or vegetation 41. Left ventricular thrombus 42. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure 43. Complex coronary artery disease: 1. Unprotected left main coronary artery disease ≥50% 2. Syntax score \&amp;gt;32 (in the absence of prior revascularization) 3. Heart Team determines that optimal revascularization cannot be adequately performed with EITHER CABG at the time of SAVR OR PCI at least 30 days prior to THV implant.

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic insufficiency Aortic regurgitation Aortic valve insufficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

34 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ascension St. Vincent Heart Center
RECRUITING

Carmel, Indiana, 46290, United States
BayCare Health
RECRUITING

Clearwater, Florida, 33756, United States
Baylor Scott & White Health
RECRUITING

Plano, Texas, 75074, United States
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02420, United States
Buffalo General Medical Center
RECRUITING

Buffalo, New York, 14203, United States
CPMC Sutter Health
RECRUITING

Burlingame, California, 94010, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Columbia University Medical Center
RECRUITING

New York, New York, 10032, United States
Deborah Heart and Lung Center
RECRUITING

Browns Mills, New Jersey, 08015, United States
Emory University Hospital
RECRUITING

Atlanta, Georgia, 30308, United States
HCA North Florida
RECRUITING

Gainesville, Florida, 32605, United States
Heart Care Centers of IL / Hinsdale Hospital
RECRUITING

Chicago, Illinois, 60521, United States
Henry Ford Health
RECRUITING

Detroit, Michigan, 48202, United States
Houston Methodist Research Institute
RECRUITING

Houston, Texas, 77030, United States
Intermountain Health
RECRUITING

Murray, Utah, 84107, United States
Lankenau Institute for Medical Research
RECRUITING

Philadelphia, Pennsylvania, 19096, United States
Los Robles Medical Center
RECRUITING

Thousand Oaks, California, 91360, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
MedStar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Ohio Health
RECRUITING

Columbus, Ohio, 43214, United States
Oregon Health & Science University (OHSU)
RECRUITING

Portland, Oregon, 97239, United States
Piedmont Healthcare
RECRUITING

Atlanta, Georgia, 30369, United States
Robert Wood Johnson University Hospital
RECRUITING

New Brunswick, New Jersey, 08901, United States
Saint Luke's Hospital of Kansas City
RECRUITING

Kansas City, Missouri, 64131, United States
Scripps Health
RECRUITING

La Jolla, California, 92037, United States
Sentara Norfolk
RECRUITING

Norfolk, Virginia, 23507, United States
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Washington
RECRUITING

Seattle, Washington, 98195, United States
Washington University - Barnes Jewish Hospital
RECRUITING

St Louis, Missouri, 63110, United States

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