NCT02227121

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
4 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 13, 2017

Completed
Last Updated

February 13, 2017

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

August 22, 2014

Results QC Date

December 20, 2016

Last Update Submit

December 20, 2016

Conditions

Ventricular Arrhythmias

Outcome Measures

Primary Outcomes (1)

  • Defibrillation Outcome

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

    Day of procedure

Study Arms (1)

VT/VF induction and defibrillation

EXPERIMENTAL

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

Interventions

Defibrillation following induction of VT/VFDEVICE

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

VT/VF induction and defibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Results Point of Contact

Title
Griet Wouters
Organization
Medtronic Cardiac Rhythm and Heart Failure
MedtronicCRMtrials@medtronic.com
800-328-2518

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 27, 2014

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

February 13, 2017

Results First Posted

February 13, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)PL(1)NL(2)GB(3)