Acute Study to Collect Electrical Signals From the Heart Using a Special Lead

June 18, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure

Acute Extravascular Defibrillation Study

The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia
        • Austin Hospital
  • Belgium
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • UZ Leuven - Campus Gasthuisberg
  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada
        • Royal Columbian Hospital
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre - University Campus
    • Quebec
      • Quebec City, Quebec, Canada
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Hong Kong
      • Kowloon, Hong Kong
        • Prince of Wales Hospital
  • Hungary
      • Budapest, Hungary
        • Semmelweis University
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum (AMC)
      • Maastricht, Netherlands
        • Maastricht Universitair Medisch Centrum
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
  • Poland
      • Kraków, Poland
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Zabrze, Poland
        • Slaskie Centrum Chorob Serca
  • Spain
      • Cordoba, Spain
        • Hospital Universitario Reina Sofia
  • Taiwan
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
  • United Kingdom
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital
      • London, United Kingdom
        • King's College of London
      • Oxford, United Kingdom
        • John Radcliffe Hospital Oxford
      • Southampton, United Kingdom
        • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Arizona Arrhythmia Consultants
    • Connecticut
      • Hartford, Connecticut, United States
        • Hartford Hospital
    • Florida
      • Jacksonville, Florida, United States
        • Baptist Medical Center Jacksonville
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
    • Iowa
      • Des Moines, Iowa, United States
        • Iowa Heart Center
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland Medical Center
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic (Rochester MN)
    • New Jersey
      • Cherry Hill, New Jersey, United States
        • Lourdes Cardiology Services
      • Morristown, New Jersey, United States
        • Morristown Memorial Hospital
    • New York
      • New York, New York, United States
        • NYU Langone Medical Center
      • New York, New York, United States
        • New York-Presbytarian Hospital / Well Cornell Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States
        • Raleigh Cardiology Associates
    • Ohio
      • Columbus, Ohio, United States
        • The Ohio State University Wexner Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
        • Lancaster General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
    • cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or
    • VT ablation procedure with epicardial access, or
    • implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber)
  • Subject must be willing to provide Informed Consent
  • Subject must be ≥ 18 years old

Exclusion Criteria:

  • Subject has known hiatus hernia or moderate or worse pectus excavatum
  • Subject had previous pericarditis or prior sternotomy
  • Subject has known significant Right Ventricle/ Right Ventricular dilation
  • Subject has hypertrophic cardiomyopathy
  • Subject is pacemaker dependent
  • Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
  • Subject is considered to be at high risk for infection(1)
  • Subject has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months)
  • Subject has New York Heart Association Class IV
  • Subject has myocardial infarction within the last 6 weeks
  • Subject currently has unstable angina
  • Subject has severe aortic stenosis
  • Subject at high risk of stroke (2)
  • Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent
  • Subject has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure (3)
  • Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
  • 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 any medical condition that would limit study participation
  • Subject is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 Acute Testing procedure
  • Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)

  • Subject is legally incompetent

    1. Screening subjects at high risk for infection will be based on the local investigator judgment decision.
    2. Subjects who are at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
    3. Screening will be based on the local investigator judgment decision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VT/ VF induction and defibrillation
Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and termination through use of a defibrillator, will be carried out as the intervention in all subjects undergoing study procedures.
Device: Defibrillation following induction of VT/VF
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
Time Frame: Day of procedure
Collect extravascular EGMs during induced VF/VT and intrinsic rhythms directly from an investigational lead placed in the extravascular space to be used for development of a future ICD.
Day of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD2
  • U1111-1179-2213 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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