J-Valve to Treat Aortic Regurgitation via Transcatheter Therapy

What is the Purpose of this Study?

The purpose of this study is to learn about the safety and performance of an experimental device called the J-Valve TF System. The device is designed to treat severe aortic regurgitation, (AR). AR occurs when the aortic valve does not close properly, which causes blood to leak back into the heart. People with severe symptomatic AR who are considered at high risk to open surgical aortic valve replacement will be suitable for the study. When compared to open chest surgery, the study procedure is less invasive, as it is performed through catheters in the Cath Lab. Patients enrolled and participating in the study will be followed by clinic visits up to 5 years.


Eligibility

  • 1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
  • 2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory:
  • A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4)
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

J-Valve to Treat Aortic Regurgitation via Transcatheter Therapy

Study Details
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00004030

ClinicalTrials.gov ID

NCT06455787

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

JCM-002

ClinicalTrials.gov ID

NCT06455787

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org