Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-12-09
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAVR in LVAD Patients
Transcatheter Aortic Valve Replacement (TAVR)
TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR)
JenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System
Interventions
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JenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System
Eligibility Criteria
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Inclusion Criteria
• 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
2. Patient with NYHA functional class III/IV
3. Patient with high risk for SAVR as documented by Heart Team.
4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
5. Patient or the patient's legal representative has provided written informed consent
6. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits
Exclusion Criteria
2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
3. Mitral regurgitation \> moderate
4. 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
5. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
6. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
7. Hypertrophic cardiomyopathy with or without obstruction
8. Severe pulmonary hypertension (systolic PA pressure \>80 mmHg)
9. 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
10. Severe RV dysfunction as assessed clinically and by echocardiography
11. Aortic annular diameter of \<21.0 mm or \> 28.6 mm (assessed by Multi-detector CT measurement)
12. Aortic annulus angulation \> 70° (assessed by Multi-detector CT measurement)
13. Straight length of ascending aorta of \< 55 mm
14. 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)
15. Myocardial infarction \< 30 days prior to index procedure
16. Cerebrovascular event (TIA, stroke) \< 180 days prior to index procedure
17. 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)
18. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to index procedure
19. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated
20. Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing
21. 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)
18 Years
ALL
No
Sponsors
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JenaValve Technology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nir Uriel, MD
Role: STUDY_CHAIR
Columbia University
Vinod Thourani, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Ravi Ramana, DO
Role: PRINCIPAL_INVESTIGATOR
advocate christ medical center
Gabriel Sayer, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Piedmont
Atlanta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Washington University, St. Louis
St Louis, Missouri, United States
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, United States
Houston Methodist Research Center
Houston, Texas, United States
Intermountain
Murray, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Countries
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Central Contacts
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Related Links
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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.
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.
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 Cannula
Other Identifiers
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JVT24002
Identifier Type: -
Identifier Source: org_study_id