UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Acronym
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Scientific Title
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Scientific Title:Acronym
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Region
| Japan |
Condition
Condition
Indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, lifethreatening ventricular tachyarrhythmias.
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of the EV ICD Japan study is to characterize acute performance of the EV ICD System for Japanese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
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.
Key secondary outcomes
. 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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
EV-ICD
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Arrhythmia Department
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
81-6-6170-1070
webadmin@ml.ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Yamamoto |
Organization
Medtronic Japan Co., Ltd.
Division name
Clinical Research Division 1, Clinical Research and Medical Science
Zip code
108-0075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
080-4671-6498
Homepage URL
takuto.yamamoto@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University IRB
Address
8-1 Kawada, Shinjyuku-ku, Tokkyo
Tel
03-5269-7839
pms-keiyaku.bm@twmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045001
