ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study

Yamamoto Takuto0 sites15 target enrollmentJune 15, 2022

Overview

No summary available.

Registry

who.int

Start Date

June 15, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yamamoto Takuto

•1\.Patient has a Class I or IIa indication for implantation of an ICD 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 implant or leads.
•4\.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.