MiRus_Siegel TAVR

What is the Purpose of this Study?

To evaluate the safety and feasibility of Siegel? TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.


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