Trial ID or NCT#

NCT02184442

Status

NOT RECRUITING

Purpose

The purpose of this post approval study is to determine the safety, effectiveness and learning curve of the SAPIEN™ THV with the Retroflex delivery system for Inoperable Patients and with the SAPIEN™ THV with Retroflex and Ascendra delivery systems for high risk operable patients with Severe Symptomatic Native Aortic Stenosis via all access sites.

Official Title

Assessment of Safety, Effectiveness, Adherence to Indication and Learning Curve of the SAPIEN™ THV With Retroflex for Inoperable Patients and With RetroFlex or Ascendra for High Risk Operable Patients Post Approval Period (US)

Eligibility Criteria

Ages Eligible for Study: Older than 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Rajesh Dash, MD, PhD, Medical & Scientific Director, SSATHI
Cardiologist
Assistant Professor of Medicine (Cardiovascular Medicine) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Spectrum Child Health
(650) 724-1175