Actively Recruiting
Transcatheter Aortic Valve Replacement Using the JenaValve Trilogy Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices
Led by JenaValve Technology, Inc. · Updated on 2026-04-01
50
Participants Needed
15
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the JenaValve Trilogy Heart Valve System for transcatheter aortic valve replacement (TAVR) in patients who have continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR). The study focuses on those who need TAVR and aims to understand how well this device works and performs in this specific group. Participants will receive TAVR using the JenaValve Trilogy Heart Valve System. This device is designed for patients with cfLVAD and significant AR. The study includes a treatment period where the device is implanted, followed by monitoring of device success, positioning, performance, and related surgical interventions. Safety aspects such as bleeding, stroke, kidney injury, vascular complications, pacemaker implantation, and mortality will be evaluated at 30 days and up to one year. During the study, participants will undergo assessments to monitor the device and their health. These include evaluations of device success, positioning, and performance, as well as checking for complications like bleeding, stroke, kidney injury, and mortality at 30 days and one year. Follow-up visits are required for ongoing monitoring. The study will continue until August 2027, with detailed data collection on health outcomes and device-related effects.
CONDITIONS
Brief Title
The JenaValve ALIGN-AR LVAD Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with continuous flow left ventricular assist devices (cfLVAD)
- Clinically significant aortic regurgitation graded 3 or higher leading to cfLVAD dysfunction
- New York Heart Association (NYHA) functional class III or IV
- High risk for surgical aortic valve replacement (SAVR) as determined by Heart Team
- Suitable anatomy for the JenaValve Trilogy Heart Valve System insertion and delivery
- Provided written informed consent or legal representative consent
- Agree to comply with all required post-procedure follow-up visits
You will not qualify if you...
- Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
- Previous prosthetic aortic valve implant (bioprosthesis or mechanical)
- Mitral regurgitation greater than moderate
- Significant coronary artery disease requiring revascularization within 30 days before or planned within 12 months after procedure
- Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
- Ongoing sepsis or active infective endocarditis with antibiotic therapy or positive blood cultures within 6 weeks
- Hypertrophic cardiomyopathy with or without obstruction
- Severe pulmonary hypertension (systolic pulmonary artery pressure over 80 mmHg)
- Decompensated right heart failure or severe right ventricular dysfunction
- Aortic annular diameter less than 21.0 mm or greater than 28.6 mm
- Aortic annulus angulation over 70 degrees
- Ascending aorta length less than 55 mm or significant disease including aneurysm or atheroma
- Myocardial infarction within 30 days prior to procedure
- Cerebrovascular event within 180 days prior to procedure
- Blood disorders causing leukopenia, thrombocytopenia, or anemia below specified levels
- Active peptic ulcer or upper gastrointestinal bleeding within 90 days prior to procedure
- Known allergies or contraindications to aspirin, heparin, ticlopidine, clopidogrel, nitinol, tantalum, or contrast agents
- Unable to undergo required pre-procedure imaging for aortic sizing
- Enrolled in another investigational medical device or drug study without completed primary endpoint follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate recovery period
Participants receive a transcatheter aortic valve replacement (TAVR) using the JenaValve Trilogy Heart Valve System to treat clinically significant aortic regurgitation while having a left ventricular assist device.
1 procedure visit and several immediate post-procedure visits
Duration - 30 days and up to 1 year
Participants are monitored for device success, positioning, performance, and complications following the valve replacement.
Multiple visits for follow-up assessments up to 1 year
Trial Site Locations
Total: 15 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Sutter Health
San Francisco, California, United States, 94109
Actively Recruiting
3
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
5
Piedmont
Atlanta, Georgia, United States, 30309
Actively Recruiting
6
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
7
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
9
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
10
Washington University, St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
11
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
12
Houston Methodist Research Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Baylor
Plano, Texas, United States, 75024
Actively Recruiting
14
Intermountain
Murray, Utah, United States, 84107
Actively Recruiting
15
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
D
David Haan
D
Duane Pinto
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here