Overview

This trial is active, not recruiting.

Condition aortic stenosis
Sponsor Institut für Pharmakologie und Präventive Medizin
Start date February 2013
End date May 2015
Trial size 303 participants
Trial identifier NCT01991431, U1111-1149-9900

Summary

This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites

Primary Outcomes

Measure
Overall mortality
time frame: 30 days

Secondary Outcomes

Measure
TAVI-related in-Hospital and 30 d mortality
time frame: 30 days after TAVI
complication rates
time frame: 30 days after TAVI
Number of Patients with adverse Events in Relation to Baseline Parameters
time frame: 30 days after TAVI

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Intended transaortic (Tao) TAVI using Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System - Compliance with the indications according to the Instructions for Use - Written informed consent Exclusion Criteria: - Presence of contraindications as to the Instructions for Use - TAo with concomitant procedure (e.g. Tao + CABG) - Participation in the SOURCE XT registry

Additional Information

Official title Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve
Principal investigator Vinayak Bapat, MD
Description The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing transaortic transcatheter procedure with the commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ System.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Institut für Pharmakologie und Präventive Medizin.