Status:
TERMINATED
Acute Defibrillation Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Ventricular Arrhythmias
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.
Detailed Description
The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclu...
Eligibility Criteria
Inclusion
- Subject must be undergoing surgical procedure for approved indications for
- cardiothoracic surgery where a midline sternotomy is planned, or
- implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or
- VT ablation procedure, or
- VT inducibility testing during Electrophysiology (EP) study
- Subject must be willing to provide Informed Consent
- Subject must be ≥ 18 years old
Exclusion
- Subject is considered to be at high risk for infection
- Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20%
- Subject at high risk of stroke
- Subject with an implanted active cardiac or non-cardiac device during study procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- Subject is pacemaker dependent
- Subject had previous pericarditis or prior sternotomy
- Subject has hiatus hernia or moderate or worse pectus excavatum
- Subject has hypertrophic cardiomyopathy
- Subject has severe aortic stenosis
- Subject has severe proximal three vessel coronary disease (over 70% in each vessel)
- Subject has \>50% left main stem (LMS) disease
- Subject has known skin irritations to the Physio Control Fast Patch ECG Electrode
- Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- Subject has medical conditions that would limit study participation
- Subject is pregnant
- Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02227121
Start Date
February 1 2015
End Date
December 1 2015
Last Update
February 13 2017
Active Locations (7)
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1
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
2
Academisch Medisch Centrum
Amsterdam, Netherlands
3
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
4
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, Poland, 31-202