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New treatment option for Aortic Regurgitation
Official title The JenaValve ALIGN-AR LVAD Registry
ClinicalTrials.gov ID: NCT06594705
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people \>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE...
- 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...
- Patient with NYHA functional class III/IV
- Patient with high risk for SAVR as documented by Heart Team.
- Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
You likely can't join if
- Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Mitral regurgitation \> moderate
- Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD...
- Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
- Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
See the full eligibility criteria
- people \>=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 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...
- Patient with NYHA functional class III/IV
- Patient with high risk for SAVR as documented by Heart Team.
- Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
- Patient or the patient's legal representative has provided written informed consent
- Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits
- Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Mitral regurgitation \> moderate
- 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
- Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
- Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
- Hypertrophic cardiomyopathy with or without obstruction
- Severe pulmonary hypertension (systolic PA pressure \>80 mmHg)
- 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 \<...
- Severe RV dysfunction as assessed clinically and by echocardiography
- Aortic annular diameter of \ 28.6 mm (assessed by Multi-detector CT measurement)
- Aortic annulus angulation \> 70° (assessed by Multi-detector CT measurement)
- Straight length of ascending aorta of \< 55 mm
- 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)
- Myocardial infarction \< 30 days prior to index procedure
- Cerebrovascular event (TIA, stroke) \< 180 days prior to index procedure
- 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)
- Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to index procedure
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated
- Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Oak Lawn, Illinois, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Houston, Texas, United States
- Plano, Texas, United States
- Murray, Utah, United States
- Norfolk, Virginia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Oak Lawn, Illinois, United States; Ann Arbor, Michigan, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.