Status:
ACTIVE_NOT_RECRUITING
The JenaValve ALIGN-AR Pivotal Trial
Lead Sponsor:
JenaValve Technology, Inc.
Conditions:
Aortic Regurgitation
Aortic Valve Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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 hear...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04415047
Start Date
May 22 2020
End Date
August 1 2028
Last Update
September 13 2022
Active Locations (30)
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1
TMC HealthCare & PIMA Heart
Tucson, Arizona, United States, 85712
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
Scripps Hospital
San Diego, California, United States, 92121
4
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94109