Japan VAD Council,
IMPELLA Committee

The Council for Clinical Use of Ventricular Assist Device Related Academic Societies has launched the Registry project for circulatory assist pump catheters (hereafter, “Catheter VAD”), in order to understand the information related to its clinical usage and performance, and to study (analyze) those factors affecting improvement of survival rate and prognosis, for the clinical evaluation and management of lifesaving treatment of patients in acute heart failure, such as cardiogenic shock.

We greatly appreciate the support of members of related societies and relevant institutions.

IMPELLA Committee

(Chairperson) Yoshiki Sawa
(Committee members) Minoru Ono, Naoki Sato, Morimasa Takayama, Koichi Toda, Atsushi Hirayama, Satoshi Yasukochi
(Committee member in charge of Facility qualification) Takashi Nishimura


Purpose:

The project aims to understand the information related to clinical usage and performance of Catheter VAD, and to study (analyze) those factors affecting improvement of survival rate and prognosis, for the clinical evaluation and management of lifesaving treatment of patients in acute heart failure, such as cardiogenic shock, The project will also identify clinical risks and benefits of Catheter VAD, promote appropriate safety measures, and utilize in the penetration of Catheter VAD appropriate use.

Main Objectives:

  1. Joint research through data collection and analysis at multiple centers is essential for the penetration of appropriate Catheter VAD use in Japan.
  2. Search for those factors affecting improvement of survival rate and prognosis, for the clinical evaluation and management of lifesaving treatment of patients in acute heart failure, such as cardiogenic shock, is believed to be one of the missions assigned to The Council for Clinical Use of Ventricular Assist Device Related Academic Societies.
  3. The Council for Clinical Use of Ventricular Assist Device Related Academic Societies hopes to disseminate EBM of Catheter VAD to the world, and to contribute to both Japan and international guidelines.

Plan:

  1. The project is a clinical study under the Appropriate Use Guidance for IMPELLA established by the IMPELLA committee of the Council for Clinical Use of Ventricular Assist Device Related Academic Societies. This study is conducted pursuant to “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)” (hereinafter the “guidelines”).
  2. The objective of this study is to mainly collect the following items:
    • Patient background and disease status
    • Survival rate at the time of hospital discharge after the device use, and 30 days after removal of the device
    • Outcome and rate of adverse events associated with the use of the device
    • Device failure and device information
    • Other information available at the Facility, which is necessary for evaluating device effectiveness
  3. The study will include all patients in whom Catheter VAD is used at all Facilities.
  4. The data of this Registry may be used for post marketing surveillance (“PMS”) and other clinical studies that are determined by the IMPELLA Committee to be necessary.
  5. This Registry is a multicenter observation and research (without intervention). Facilities may be requested to provide additional information on cases when the IMPELLA Committee deems it necessary.
  6. In this Registry, case data submitted to the IMPELLA Committee Office should not include any information that can identify patients, in order to fully protect personal information of the patients.
  7. The research information about this Registry is published in this website (opt-out). If a patient declines to participate in this Registry, each Facility must report this to IMPELLA committee by e-mail or etc.
  8. In addition to the above, any details not included will follow objectives of the Guidance.

【Materials】

The following materials will be provided as necessary after Facility qualification:


Contact:

Council for Clinical Use of Ventricular Assist Device Related Academic Societies, IMPELLA Committee Office
Attn: J-PVAD Registry Coordinator
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