Improve Research Reproducibility A Bio-protocol resource
Concise Method
tooltip

2.1. Study Design

WK Won-Keun Kim
HT Holger Thiele
AL Axel Linke
TK Thomas Kuntze
SF Stephan Fichtlscherer
JW John Webb
MC Michael W. A. Chu
MA Matti Adam
GS Gerhard Schymik
TG Tobias Geisler
RK Rajesh Kharbanda
TC Thomas Christen
DA Dominic Allocco
ask Ask a question
Favorite

PROGRESS PVL is a multicenter open-label single-arm study. Patients were considered eligible if they presented with severe aortic stenosis and were determined by a heart team to be at high risk for surgical valve replacement based on the patient's Society of Thoracic Surgeons (STS) score as well as the presence of other comorbidities. The protocol was approved by locally appointed institutional review boards/ethics committees. The study was conducted in accordance with the International Conference for Harmonization Good Clinical Practice (ICH-GCP) regulations and guidelines and the ethical principles outlined in the Declaration of Helsinki and registered with ClinicalTrials.gov (NCT02987894). All patients gave written informed consent.

Copyright and License information:  ©2022 Won-Keun Kim et al.
This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Do you have any questions about this protocol?

Post your question to gather feedback from the community. We will also invite the authors of this article to respond.

post Post a Question
0 Q&A