Actively Recruiting
The JenaValve ALIGN-AR LVAD Registry
Led by JenaValve Technology, Inc. · Updated on 2026-04-01
50
Participants Needed
15
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The JenaValve ALIGN-AR LVAD Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with continuous flow left ventricular assist device (cfLVAD) and clinically significant aortic regurgitation graded 3 or higher
- New York Heart Association (NYHA) functional class III or IV
- High risk for surgical aortic valve replacement as assessed by Heart Team
- Suitable anatomy for insertion and delivery of the JenaValve Trilogy Heart Valve System
- Provided written informed consent or consent given by legal representative
- Agree to comply with all required post-procedure follow-up visits
You will not qualify if you...
- Congenital uni- or bicuspid aortic valve morphology (Sievers 0)
- Previous prosthetic aortic valve implant (mechanical or bioprosthesis)
- Mitral regurgitation greater than moderate
- Clinically significant coronary artery disease requiring revascularization within 30 days prior or planned within 12 months after procedure
- Evidence of left ventricular or aortic valve thrombus on imaging
- 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 >80 mmHg)
- Decompensated right heart failure clinically or by catheterization
- Severe right ventricular dysfunction by clinical assessment and echocardiography
- Aortic annulus diameter less than 21.0 mm or greater than 28.6 mm (by CT scan)
- Aortic annulus angulation greater than 70 degrees (by CT scan)
- Ascending aorta length less than 55 mm
- Significant disease of ascending aorta including aneurysm (diameter ≥50 mm) or atheroma (thick, protruding or ulcerated)
- Myocardial infarction within 30 days before procedure
- Cerebrovascular event (TIA or stroke) within 180 days before procedure
- Blood disorders including low white blood cells, platelets, or severe anemia
- Active peptic ulcer or upper gastrointestinal bleeding within 90 days before procedure
- Allergy or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, tantalum, or contrast agents that cannot be premedicated
- Unable to undergo required pre-procedure echocardiography or CT scan for valve sizing
- Enrolled in another investigational device or drug study without completing required primary endpoint follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
Duane Pinto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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