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First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System — SJM TAVI FIH  

Symptomatic Aortic Stenosis Clinical Trial

Official title:
First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)

Clinical Trial Summary

The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS).

This is a single center, prospective, non-randomized, first-in-human investigational study without concurrent or matched controls.

Clinical Trial Description

Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01487330
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date August 2011
Completion date September 2012
View Details
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