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 2023/11/15 13:36:48

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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

Email

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

OU Clinical Division 1, Japan Clinical and Medical Affairs

Zip code

108-0075

Address

1-2-70 Konan, Minato-ku, Tokyo

TEL

080-4671-6498

Homepage URL


Email

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

Email

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


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

Open public 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

2025 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 13 Day

Last modified on

2023 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045001


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name