Request To Participate In The Academic Research (Registry)
The purpose of this Registry is to utilize the data for the clinical evaluation and management of lifesaving treatment of patients in acute heart failure, such as cardiogenic shock, through understanding and analyzing the status of Circulatory Assist Pump Catheter usage and its performance, as well as investigating (analyzing) those factors affecting improvement of survival rate and prognosis. Also by identifying clinical risks and benefits of the Pump Catheter, appropriate safety measures can be promoted, which we hope will be instrumental in the penetration of its appropriate use.
For these purposes, the data of every patient in whom Circulatory Assist Pump Catheter is used will be collected. If you do not wish to participate in the research, please contact the physician at the hospital that the device was used.
This research is conducted based on the Appropriate Use Guidance established by The Council for Clinical Use of Ventricular Assist Device Related Academic Societies, IMPELLA committee. This research is conducted in compliance with the "Ethical Guidelines for Medical and Health Research Involving Human Subjects (Public Notice of the Ministry of Education, Culture, Sports, Science and Technology/the Ministry of Health, Labour and Welfare No. 3 of 2014)".
Subject: All patients at all the facilities in whom the Circulatory Assist Pump Cather is used.
Main data to be collected are as follows:
Patient background and disease status
Survival rate after device use, at discharge, and 30 days after device removal
Outcome and adverse event rate associated with the use of the device
Device failure and device information
Other information available, which is necessary for evaluating device effectiveness
Data from this registry will be collected through electronic data system, and provided to the Impella Committee.
The data may be used for the Post Marketing Surveillance as well as other clinical research approved by the Impella Committee to be necessary
This Registry is multi-center observational research (without intervention). Facilities may be requested by the IMPELLA Committee to provide additional information on cases as necessary.
In order to completely protect personal information of the patient, data submitted to the Committee Office should not include any identifiable information.
For enquiries, please contact:
Council for Clinical Use of Ventricular Assist Device Related Academic Societies
IMPELLA Committee Office