The JenaValve ALIGN-AR Pivotal Trial
- Conditions
- Aortic Valve InsufficiencyAortic InsufficiencyAortic Valve DiseaseAortic Regurgitation
- Interventions
- Device: JenaValve Trilogy Heart Valve System
- Registration Number
- NCT04415047
- Lead Sponsor
- JenaValve Technology, Inc.
- Brief Summary
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
- Detailed Description
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Patient with severe aortic regurgitation (AR).
- Patient at high risk for open surgical valve replacement
- Patient symptomatic according to NYHA functional class II or higher
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
- Congenital uni or bicuspid aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Endocarditis or other active infection
- Need for urgent or emergent TAVR procedure for any reason
- Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
- Severe mitral regurgitation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transcatheter Aortic Valve Replacement (TAVR) JenaValve Trilogy Heart Valve System TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System
- Primary Outcome Measures
Name Time Method Major Vascular Complications 30 days Number of patients that had these events
Acute Kidney Injury 30 days Number of patients that had these events
All Stroke 30 days Number of patients that had a stroke
Surgery/intervention related to the device 30 days Number of patients that had these events
Permanent pacemaker implantation 30 days Number of patients that had these events
All-Cause Mortality at 1 Year 1 year All-cause mortality within the first 12 months post index procedure
Major Bleeding 30 days Number of patients that had any of these events
Total aortic regurgitation 30 days Number of patients that had these events
- Secondary Outcome Measures
Name Time Method KCCQ 1 year KCCQ Improvement
Trial Locations
- Locations (30)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Morton Plant/ BayCare Health
🇺🇸Clearwater, Florida, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Barnes-Jewish Hospital / Washington University
🇺🇸Saint Louis, Missouri, United States
Allegheny-Singer Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Memorial Hermann - Texas Medical Center
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Scripps Hospital
🇺🇸San Diego, California, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
New York-Presbyterian/ Columbia University Medical Center
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
TMC HealthCare & PIMA Heart
🇺🇸Tucson, Arizona, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital
🇺🇸Piscataway, New Jersey, United States
Methodist Le Bonheur Healthcare
🇺🇸Memphis, Tennessee, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
California Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Minneapolis Heart Institute/ Abbott Northwestern
🇺🇸Minneapolis, Minnesota, United States
Intermountain Medical Center Heart Institute
🇺🇸Salt Lake City, Utah, United States
Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health
🇺🇸Oak Lawn, Illinois, United States
Lankenau
🇺🇸Wynnewood, Pennsylvania, United States
Sentara Hospitals
🇺🇸Norfolk, Virginia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States