Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062556) titled 'The Japan Surgical Unloading Renal Protection and Sustainable Support Study (SURPASS JP)' on Aug. 12.
Study Type:
Observational
Primary Sponsor:
Institute - ABIOMED, Inc. (Sponsor)
Condition:
Condition - Patients who receive Impella 5.5 support as standard of care
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To document quality performance measures assessing the post-market surgical performance and clinical management of patients supported with Impella 5.5, and to identify factors influencing treatment strategies for Impella 5.5
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
= 18 years of age
Key exclusion criteria - 1. Informed consent was not obtained during the index hospitalization
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 03 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071607
Disclaimer: Curated by HT Syndication.