RECRUITING

The JenaValve ALIGN-AR LVAD Registry

Conditions

Aortic Regurgitation Aortic Valve Insufficiency Aortic Insufficiency Aortic Valve Disease Left Ventricular Dysfunction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)

Quick Facts

Study Start:2024-12-09

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06594705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects \&gt;=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3: 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	1. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology 2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant 3. Mitral regurgitation \&gt; 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 \&gt;80 mmHg) 9. Decompensated right heart failure as based on baseline right heart catheterization findings: right atrial pressure \&gt; pulmonary capillary wedge pressure and cardiac index \&lt; 2.5 ml/L/m2 10. Severe RV dysfunction as assessed clinically and by echo 11. Aortic annular diameter of \&lt;21.0 mm or \&gt; 28.6 mm (assessed by Multi-detector CT measurement) 12. Chronic Kidney Disease Stage 4 or 5 (\&lt;30 cc/min/1.73 m2 or dialysis) 13. Aortic annulus angulation \&gt; 70° (assessed by Multi-detector CT measurement) 14. Straight length of ascending aorta of \&lt; 55 mm 15. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \[\&gt;5 mm\], protruding or ulcerated) 16. Need for urgent or emergent TAVR procedure for any reason 17. Myocardial infarction \&lt; 30 days prior to index procedure 18. Cerebrovascular event (TIA, stroke) \&lt; 180 days prior to index procedure 19. Blood dyscrasias as defined: leukopenia (WBC \&lt; 3000/mm³), or thrombocytopenia (platelets \&lt; 90,000/μl) or anemia (Men: Hgb \&lt; 8.1 g/dl; Women: Hgb \&lt; 7.4 g/dl) 20. Active peptic ulcer or upper gastrointestinal bleeding \&lt; 90 days prior to index procedure 21. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated

Inclusion Criteria

Exclusion Criteria

1. Subjects \&gt;=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:
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

1. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
3. Mitral regurgitation \&gt; 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 \&gt;80 mmHg)
9. Decompensated right heart failure as based on baseline right heart catheterization findings: right atrial pressure \&gt; pulmonary capillary wedge pressure and cardiac index \&lt; 2.5 ml/L/m2
10. Severe RV dysfunction as assessed clinically and by echo
11. Aortic annular diameter of \&lt;21.0 mm or \&gt; 28.6 mm (assessed by Multi-detector CT measurement)
12. Chronic Kidney Disease Stage 4 or 5 (\&lt;30 cc/min/1.73 m2 or dialysis)
13. Aortic annulus angulation \&gt; 70° (assessed by Multi-detector CT measurement)
14. Straight length of ascending aorta of \&lt; 55 mm
15. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \[\&gt;5 mm\], protruding or ulcerated)
16. Need for urgent or emergent TAVR procedure for any reason
17. Myocardial infarction \&lt; 30 days prior to index procedure
18. Cerebrovascular event (TIA, stroke) \&lt; 180 days prior to index procedure
19. Blood dyscrasias as defined: leukopenia (WBC \&lt; 3000/mm³), or thrombocytopenia (platelets \&lt; 90,000/μl) or anemia (Men: Hgb \&lt; 8.1 g/dl; Women: Hgb \&lt; 7.4 g/dl)
20. Active peptic ulcer or upper gastrointestinal bleeding \&lt; 90 days prior to index procedure
21. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated

Contacts and Locations

Study Contact

Lisa Boyle

CONTACT

949-767-2110

boyle@jenavalve.com

Duane Pinto

CONTACT

949-767-2110

pinto@jenavalve.com

Principal Investigator

Nir Uriel, MD

STUDY_CHAIR

Columbia University

Vinod Thourani, MD

PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Ravi Ramana, DO

PRINCIPAL_INVESTIGATOR

advocate christ medical center

Gabriel Sayer, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Washington University in St. Louis

St. Louis, Missouri, 63130

United States

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, 10032

United States

Houston Methodist Research Center

Houston, Texas, 77030

United States

Intermountain

Murray, Utah, 84107

United States

Collaborators and Investigators

Sponsor: JenaValve Technology, Inc.

Nir Uriel, MD, STUDY_CHAIR, Columbia University
Vinod Thourani, MD, PRINCIPAL_INVESTIGATOR, Piedmont Heart Institute
Ravi Ramana, DO, PRINCIPAL_INVESTIGATOR, advocate christ medical center
Gabriel Sayer, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12-09

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Aortic Regurgitation
Aortic Valve Insufficiency
Aortic Insufficiency
Aortic Valve Disease
Left Ventricular Dysfunction