Acute Defibrillation Study

The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.

Study Overview

• Status: Terminated
• Conditions: Ventricular Arrhythmias
• Intervention / Treatment: Device: Defibrillation following induction of VT/VF

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 inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure.

The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care.

Subjects were followed through their routine post-surgery follow-up visit.

At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories
    • Sha Tin, New Territories, Hong Kong
      • Prince of Wales Hospital
• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
• Poland
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny Im. Jana Pawla Ii
• United Kingdom
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VT/VF induction and defibrillation; Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defibrillation Outcome	Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.	Day of procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: ASD Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO