Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency
Conditions
Keywords
Valvular Heart Disease, Aortic Incompetence, Aortic Valve Incompetence
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.
Interventions
TAVR with JenaValve Trilogy Heart Valve System
Sponsors
JenaValve Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total aortic regurgitation | 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 |
| All Stroke | 30 days | Number of patients that had a stroke |
| Major Bleeding | 30 days | Number of patients that had any of these events |
| Acute Kidney Injury | 30 days | Number of patients that had these events |
| Major Vascular Complications | 30 days | Number of patients that had these events |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KCCQ | 1 year | KCCQ Improvement |
Countries
United States
Outcome results
None listed