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Acute Defibrillation Study

Primary Purpose

Ventricular Arrhythmias

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Defibrillation following induction of VT/VF

About this trial

This is an interventional treatment trial for Ventricular Arrhythmias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Prince of Wales Hospital
Academisch Medisch Centrum
St. Antonius Ziekenhuis
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Liverpool Heart and Chest Hospital
King's College Hospital
Southampton General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VT/VF induction and defibrillation

Arm Description

Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.

Outcomes

Primary Outcome Measures

Defibrillation Outcome

Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.

Secondary Outcome Measures

Full Information

NCT ID

NCT02227121

First Posted

August 22, 2014

Last Updated

December 20, 2016

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT02227121

Brief Title

Acute Defibrillation Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Terminated

Why Stopped

Sufficient enrollments under current protocol for further development & studies

Study Start Date

February 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Arrhythmias

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VT/VF induction and defibrillation

Arm Type

Experimental

Arm Description

Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.

Intervention Type

Device

Intervention Name(s)

Defibrillation following induction of VT/VF

Intervention Description

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

Primary Outcome Measure Information:

Title

Defibrillation Outcome

Description

Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.

Time Frame

Day of procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Facility Information:

Facility Name

Prince of Wales Hospital

City

Sha Tin

State/Province

New Territories

Country

Hong Kong

Facility Name

Academisch Medisch Centrum

City

Amsterdam

Country

Netherlands

Facility Name

St. Antonius Ziekenhuis

City

Nieuwegein

Country

Netherlands

Facility Name

Krakowski Szpital Specjalistyczny im. Jana Pawla II

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Liverpool Heart and Chest Hospital

City

Liverpool

ZIP/Postal Code

L14 3PE

Country

United Kingdom

Facility Name

King's College Hospital

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Southampton General Hospital

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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