Portico NG Approval Study

Condition: Aortic stenosis

Eligibility

Key Inclusion Criteria

  • Society of Thoracic Surgeons score of ≥7% OR documented high or extreme risk for surgical aortic valve replacement 
  • Symptomatic severe aortic stenosis as demonstrated by New York Heart Association Functional Classification of II, III, or IV
  • Participant will return for all required post‐procedure follow‐up visits.

Key Exclusion Criteria

  • Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this study
  • Need for emergency surgery for any reason
  • Incapacitated individuals

Full Study Name

Evaluation of the Portico NG Transcatheter Aortic Valve in High and Extreme-Risk Patients With Symptomatic Severe Aortic Stenosis (ABT-CIP-10297) (IRB no. 00000152)

Summary

This study focuses on individuals with a heart valve condition (aortic stenosis) who are at high or extreme risk for open-heart surgery. The purpose of the study is to evaluate an investigational device called the Portico NG transcatheter aortic valve implantation (TAVI) system, which is used to treat aortic stenosis.

The Portico NG transcatheter heart valve can be placed into the diseased heart valve without the need for open heart surgery. The valve is attached to a stent, or scaffold, which holds the valve in position. The Portico NG valve is used in combination with the FlexNav delivery system, which can maneuver through narrow blood vessels and improve the ability to position the Portico NG valve in place. Researchers aim to collect data on the Portico NG valve and FlexNav delivery system, as well as support commercial approval of the device.


Principal Investigator

Raj Makkar, MD

Contact