ExtraVascular Implantable Cardiac Defibrillator Continued Access Study

Medtronic0 sitesSeptember 2022

ConditionsTachycardia Ventricular Arrythmia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Tachycardia
Sponsor: Medtronic
Primary Endpoint: Complications
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Detailed Description

The study will enroll subjects who are indicated to receive an implantable defibrillator who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed every 6 months following system implantation.

Registry

clinicaltrials.gov

Start Date

September 2022

End Date

July 28, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines.\[1\]
•Patient is willing and able to sign and date the Informed Consent Form for their participation in the study.
•Patient is at least 18 years of age and meets age requirements per local law.
•Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up.

Exclusion Criteria

•Patient has indications for bradycardia pacing\[2\] or Cardiac Resynchronization Therapy (CRT)\[3\] (Class I, IIa, or IIb indication).
•Patients with an existing pacemaker, ICD, or CRT device 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.
•Patients with these medical conditions or anatomies are excluded from participation in the study: