Unique ID issued by UMIN | UMIN000039469 |
---|---|
Receipt number | R000045001 |
Scientific Title | ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study |
Date of disclosure of the study information | 2020/02/29 |
Last modified on | 2024/11/01 16:19:08 |
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Japan |
Indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, lifethreatening ventricular tachyarrhythmias.
Cardiology | Adult |
Others
NO
The main purpose of the EV ICD Japan study is to characterize acute performance of the EV ICD System for Japanese patients.
Safety,Efficacy
Phase III
1. Characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant.
2. Characterize the EV ICD defibrillation testing success rate at implant.
. Characterize appropriate and inappropriate shocks
. Characterize electrical performance (pacing capture thresholds, pacing impedance, sensing amplitudes) over time
. Characterize extracardiac pacing sensation
. Characterize asystole pacing
. Summarize ATP performance with spontaneous arrhythmias
. Summarize adverse events
. Characterize EV ICD defibrillation testing conducted per physician discretion
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
EV-ICD
18 | years-old | <= |
Not applicable |
Male and Female
1. Patient has a Class I or IIa indication for implantation of anICD according to the ACC/AHA/HRS Guidelines, or ESC guidelines.
2. Patient is at least 18 years of age and meets age requirements per local law.
3. Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
1. Patient is unwilling or unable to personally provide Informed Consent.
2. Patient has indications for bradycardia pacing or Cardiac Resynchronization Therapy (CRT) (Class I, IIa, or IIb indication).
3. Patients with an existing pacemaker, ICD, or CRT device or leads.
4. Patients with these medical interventions are excluded from participation in the study:
Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
5. Patient has previous pericarditis that:
6. Patients with these medical conditions or anatomies are excluded from participation in the study:
Or any other known medical condition or anatomy type not listed that precludes their participation in the opinion of the Investigator.
7. Patients with a medical condition that precludes them from undergoing defibrillation testing:
Or any other known medical condition not listed that precludes their participation in the opinion of the Investigator.
8. Patient with any evidence of active infection or undergoing treatment for an infection
9. Patient is contraindicated from temporary suspension of oral/systemic anticoagulation
10. Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body.
11. Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 month).
12. Patient is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study,without documented pre-approval from a Medtronic study manager.
13. Patient with any exclusion criteria as required by local law (e.g., age or other).
14. Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.
15
1st name | Kengo |
Middle name | |
Last name | Kusano |
National Cerebral and Cardiovascular Center
Arrhythmia Department
564-8565
6-1 Kishibe-Shimmachi, Suita, Osaka
81-6-6170-1070
webadmin@ml.ncvc.go.jp
1st name | Takuto |
Middle name | |
Last name | Yamamoto |
Medtronic Japan Co., Ltd.
Clinical Research Division 1, Clinical Research and Medical Science
108-0075
1-2-70 Konan, Minato-ku, Tokyo
080-4671-6498
takuto.yamamoto@medtronic.com
Medtronic Japan Co., Ltd.
Medtronic Japan Co., Ltd.
Profit organization
Tokyo Women's Medical University IRB
8-1 Kawada, Shinjyuku-ku, Tokkyo
03-5269-7839
pms-keiyaku.bm@twmu.ac.jp
NO
国立循環器病研究センター(大阪府)、岡山大学病院(岡山県)、東京女子医科大学病院(東京)
2020 | Year | 02 | Month | 29 | Day |
Unpublished
14
No longer recruiting
2019 | Year | 07 | Month | 02 | Day |
2022 | Year | 06 | Month | 13 | Day |
2023 | Year | 03 | Month | 23 | Day |
2026 | Year | 01 | Month | 31 | Day |
2025 | Year | 03 | Month | 28 | Day |
2025 | Year | 04 | Month | 30 | Day |
2020 | Year | 02 | Month | 13 | Day |
2024 | Year | 11 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045001