ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study

NCT07091916 | Completed Results FDA Device

• 1 other identifier: MDT22010
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.

Conditions

Tachycardia; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (2)

• Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant

  The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.

  2 weeks (14 days) post-implant

• Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System

  Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 6 such episodes may be induced to test device efficacy.

  At Implant

Study Arms (1)

Implant Attempt

EXPERIMENTAL

Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.

Device: Defibrillation using the Extravascular ICD

Interventions

Defibrillation using the Extravascular ICD DEVICE

VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.

Implant Attempt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines \[i\], or ESC guidelines \[ii\].
• Patient is at least 18 years of age and meets age requirements per local law.
• Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
• \[i\] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias. \[ii\] Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliot PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ. 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. European Heart Journal 2015 36:41 (2793-2867). https://doi.org/10.1093/eurheartj/ehv316

You may not qualify if:

• Patient is unwilling or unable to personally provide Informed Consent.
• Patient has indications for bradycardia pacing \[iii\] or Cardiac Resynchronization Therapy (CRT) \[iv\] (Class I, IIa, or IIb indication).
• Patient with an existing pacemaker, ICD, or CRT device implant or leads.
• Patients with these medical interventions are excluded from participation in the study:
• Prior sternotomy
• Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis)
• Prior abdominal surgery in the epigastric region
• Planned sternotomy
• Prior chest radiotherapy
• Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
• Patient has previous pericarditis that:
• Was chronic and recurrent, or
• Resulted in pericardial effusion \[v\], or
• Resulted in pericardial thickening or calcification \[vi\].
• Patients with these medical conditions or anatomies are excluded from participation in the study:

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Medtronic Japan Co., Ltd.

Tokyo, 1080075, Japan

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Takuto Yamamoto
• Organization: Medtronic Japan Co., Ltd.

takuto.yamamoto@medtronic.com

+818046716498

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: February 22, 2023
• Primary Completion: November 16, 2023
• Study Completion: January 23, 2025
• Last Updated: September 3, 2025
• Results First Posted: September 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)