Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT05756751
Brief Summary:
The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.
Detailed Description:
A European, prospective, multicenter, post-market clinical single-arm follow-up trial.
Up to 123 patients will be enrolled in the study.
Patients will be followed for up to 1-year.
The objectives of the study are to collect data on the safety and on the effectiveness of the Impella 5.5 System in mitigating post-cardiotomy cardiac failure, as well as improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting.
Study:
NCT05756751
Study Brief:
Protocol Section:
NCT05756751