Acute Defibrillation Study

Ventricular Arrhythmias Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02227121
• Other study ID #: ASD Study
• Status: Terminated
• Phase: N/A
• First received: August 22, 2014
• Last updated: January 11, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Dutch Health Care InspectorateHong Kong: Ethics CommitteeUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Subject is considered to be at high risk for infection a

• Subject has Left Ventricular Ejection Fraction (LVEF) < 20%

• Subject at high risk of stroke b

• 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.)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ventricular Arrhythmias

Intervention

Device:
• Defibrillation following induction of VT/VF
Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defibrillation outcome	Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.	Day of procedure	No