Acute Extravascular Defibrillation Study

Medtronic Cardiac Rhythm and Heart Failure36 sites in 12 countries87 target enrollmentMay 2016

ConditionsTachycardia Ventricular Arrhythmias

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tachycardia
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Enrollment: 87
Locations: 36
Primary Endpoint: Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

August 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be undergoing surgical procedure for approved indications for:
•cardiothoracic surgery where a midline sternotomy is planned, or
•cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or
•VT ablation procedure with epicardial access, or
•implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber)
•Subject must be willing to provide Informed Consent
•Subject must be ≥ 18 years old

Exclusion Criteria

•Subject has known hiatus hernia or moderate or worse pectus excavatum
•Subject had previous pericarditis or prior sternotomy
•Subject has known significant Right Ventricle/ Right Ventricular dilation
•Subject has hypertrophic cardiomyopathy
•Subject is pacemaker dependent
•Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
•Subject is considered to be at high risk for infection(1)
•Subject has Left Ventricular Ejection Fraction \< 20% (most recent available LVEF measurement in the last 6 months)
•Subject has New York Heart Association Class IV
•Subject has myocardial infarction within the last 6 weeks

Outcomes

Primary Outcomes

Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes

Time Frame: Day of procedure

Collect extravascular EGMs during induced VF/VT and intrinsic rhythms directly from an investigational lead placed in the extravascular space to be used for development of a future ICD.