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

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ClinicalTrials.gov Identifier: NCT02772380
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date June 19, 2018
Study Start Date  ICMJE May 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
Official Title  ICMJE Acute Extravascular Defibrillation Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Tachycardia
  • Ventricular Arrhythmias
Intervention  ICMJE Device: Defibrillation following induction of VT/VF
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
Study Arms  ICMJE 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.
Intervention: Device: Defibrillation following induction of VT/VF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2018)
87
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
120
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Hong Kong,   Hungary,   Netherlands,   New Zealand,   Poland,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772380
Other Study ID Numbers  ICMJE ASD2
U1111-1179-2213 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP