NCT01487330

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation (TAVI)	Placement of the SJM TAVI aortic valve with a transfemoral delivery system.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2012-09-01
• First posted: 2011-12-07
• Last updated: 2019-02-04

Locations

1 site across 1 country: United Kingdom