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

Primary Purpose

Tachycardia, Ventricular Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Defibrillation following induction of VT/VF
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Tachycardia

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
    • 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.

Sites / Locations

  • Arizona Arrhythmia Consultants
  • Hartford Hospital
  • Baptist Medical Center Jacksonville
  • Northwestern University
  • Iowa Heart Center
  • University of Maryland Medical Center
  • Mayo Clinic (Rochester MN)
  • Lourdes Cardiology Services
  • Morristown Memorial Hospital
  • New York-Presbytarian Hospital / Well Cornell Medical Center
  • NYU Langone Medical Center
  • Raleigh Cardiology Associates
  • The Ohio State University Wexner Medical Center
  • Lancaster General Hospital
  • Austin Hospital
  • Universitair Ziekenhuis Gent
  • UZ Leuven - Campus Gasthuisberg
  • Royal Columbian Hospital
  • London Health Sciences Centre - University Campus
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
  • Prince of Wales Hospital
  • Semmelweis University
  • Academisch Medisch Centrum (AMC)
  • Maastricht Universitair Medisch Centrum
  • St. Antonius Ziekenhuis
  • Christchurch Hospital
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II
  • Slaskie Centrum Chorob Serca
  • Hospital Universitario Reina Sofia
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Liverpool Heart and Chest Hospital
  • King's College of London
  • John Radcliffe Hospital Oxford
  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

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 termination through use of a defibrillator, will be carried out as the intervention in all subjects undergoing study procedures.

Outcomes

Primary Outcome Measures

Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
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.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2016
Last Updated
June 18, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02772380
Brief Title
Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
Official Title
Acute Extravascular Defibrillation Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (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
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects who are undergoing a standard of care procedure will also undergo the ASD2 research procedure involving placing an investigational lead in the substernal space to gather electrograms during induced ventricular arrhythmias for future research/development.
Allocation
N/A
Enrollment
87 (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 termination through use of a defibrillator, will be carried out as the intervention in all subjects undergoing study procedures.
Intervention Type
Device
Intervention Name(s)
Defibrillation following induction of VT/VF
Intervention Description
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
Primary Outcome Measure Information:
Title
Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
Description
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.
Time Frame
Day of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Screening subjects at high risk for infection will be based on the local investigator judgment decision. 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). Screening will be based on the local investigator judgment decision.
Facility Information:
Facility Name
Arizona Arrhythmia Consultants
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Mayo Clinic (Rochester MN)
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Lourdes Cardiology Services
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
New York-Presbytarian Hospital / Well Cornell Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Raleigh Cardiology Associates
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
Country
United States
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
Country
Canada
Facility Name
London Health Sciences Centre - University Campus
City
London
State/Province
Ontario
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Prince of Wales Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II
City
Kraków
Country
Poland
Facility Name
Slaskie Centrum Chorob Serca
City
Zabrze
Country
Poland
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
Country
United Kingdom
Facility Name
King's College of London
City
London
Country
United Kingdom
Facility Name
John Radcliffe Hospital Oxford
City
Oxford
Country
United Kingdom
Facility Name
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

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

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