Siegel Transcatheter Aortic Valve Replacement System EFS Study

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental device called the Siegel Transcatheter Aortic Valve Replacement (TAVR) System is safe and effective in treating adults who have aortic stenosis, a condition in which the opening in the aortic valve is narrowed. Replacement of the valve is usually recommended when the stenosis is severe. Participants in this study are patients for whom a non-surgical procedure to replace the heart valve to treat aortic stenosis has been recommended. Participants will undergo the TAVR treatment procedure using the Siegel valve system, during which the doctor will make a small cut in the groin. A thin, flexible tube is inserted into the artery to guide the Siegel heart valve up into the heart. The valve is then expanded using a balloon to fit inside the diseased valve.


Eligibility

  • Subjects are eligible for entry in this study if all the following conditions are met:
  • 1. Symptomatic, severe native aortic stenosis in subjects 50 years or older Aortic Valve Area (AVA) ≤ 1.0 cm2 or Aortic Valve Area (AVA) index ≤ 0.6 cm2/m2 and Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index \<0.25
  • 2. New York Heart Association Functional Class ≥ 2
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Siegel Transcatheter Aortic Valve EFS Study: Use of Siegel TAVR System in Subjects With Severe Aortic Stenosis

Study Details
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

II

IRB Number

STUDY00004117

ClinicalTrials.gov ID

NCT06680427

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

II

IRB Number

MR-001

ClinicalTrials.gov ID

NCT06680427

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org