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PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry — PROGRESS  

Aortic Stenosis Clinical Trial

Official title:
Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry

Clinical Trial Summary

The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.

Clinical Trial Description

The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU).

Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments.

The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02987894
Study type Observational [Patient Registry]
Source Boston Scientific Corporation
Contact
Status Completed
Phase
Start date January 2, 2017
Completion date September 2019
View Details
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