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JenaValve AS EFS Study

Condition: Aortic stenosis

Eligibility

Key Inclusion Criteria

  • Adult patients with severe degenerative native aortic stenosis
  • Symptomatic according to New York Heart Association functional class II or higher
  • At high risk for surgical aortic valve replacement

Key Exclusion Criteria

  • Congenital uni- or bicuspid aortic valve morphology
  • Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
  • Mitral regurgitation >moderate
Please See Detailed List of Inclusion and Exclusion Criteria

Full Study Name

An Early Feasibility Study to Assess Safety and Efficacy of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS) (IRB no. 44482)

Summary

This study focuses on individuals who have been diagnosed with severe aortic stenosis (AS). Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart. The study is an early feasibility clinical trial to evaluate the investigational use of the JenaValve Pericardial TAVR System for the treatment of patients who require replacement of their aortic heart valve. An early feasibility study means that the device is experimental and is not yet in the final stages of development and clinical investigation.  

The JenaValve Pericardial TAVR System uses a transcatheter aortic valve replacement procedure, which is considered a less invasive surgery than open-heart aortic valve surgery and avoids the use of a heart-lung bypass machine.

Principal Investigator

Raj Makkar, MD

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