THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
- Conditions
- Aortic Regurgitation
- Interventions
- Device: JenaValve Pericardial TAVR System
- Registration Number
- NCT02732704
- Lead Sponsor
- JenaValve Technology, Inc.
- Brief Summary
To collect information about treatment for 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 severe aortic regurgitation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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 Pericardial TAVR System TAVR with JenaValve Pericardial Valve and Delivery System
- Primary Outcome Measures
Name Time Method All-Cause Mortality at 30 days 30 days All-Cause mortality within the first 30 days post index procedure
- Secondary Outcome Measures
Name Time Method Stroke-Free Survival At 30 days and 1 year Disabling or non-disabling stroke
Peri-Procedural Myocardial Infarction At ≤72hr after the index procedure Peri-procedural and spontaneous myocardial infarction
Mortality At 30 days Absence of procedural mortality
Bleeding & Vascular Complications 30 days Major and minor bleeding
Trial Locations
- Locations (19)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
California Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
University of Washington
🇺🇸Seattle, Washington, United States
New York-Presbyterian/ Columbia University Medical Center
🇺🇸New York, New York, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Kerckhoff-Klinik GmbH Bad Nauheim
🇩🇪Bad Nauheim, Germany
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Universitäres Herzzentrum Hamburg
🇩🇪Hamburg, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Herzzentrum der Universität zu Köln
🇩🇪Köln, Germany
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States