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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT06965504
Brief Summary:
The study will evaluate if Impella 5.5® support in heart failure reduced ejection fraction (HFrEF) patients presenting with decompensated heart failure (HF) and cardiogenic shock will facilitate the initiation and optimization of guideline directed medical therapy (GDMT) during the hospital stay and post-discharge.
Detailed Description:
This is a prospective, single arm, multi-center, post-market, on-label study. Patients presenting with HFrEF who are not on adequate GDMT and who are presenting with heart failure cardiogenic shock will be evaluated for inclusion. The study objectives are to evaluate the impact of Impella 5.5 support on GDMT up-titration during support, at discharge, and at 90-days post-discharge and to evaluate the feasibility of Impella 5.5 combined with optimal GDMT to improve heart recovery in patients with decompensated heart failure. Outcomes will be measured up to one-year post-hospital discharge.
Study:
NCT06965504
Study Brief:
Protocol Section:
NCT06965504