ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study

Phase 3

Recruiting

• Conditions: Indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, lifethreatening ventricular tachyarrhythmias.

• Registration Number: JPRN-UMIN000039469
• Lead Sponsor: Medtronic Japan Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-29
• Last Update Posted: 22 January 2024
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified