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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tachycardia Ventricular Arrhythmias Device: Defibrillation following induction of VT/VF Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
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
Official Title: Acute Extravascular Defibrillation Study
Study Start Date : May 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772380


Locations
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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02772380    
Other Study ID Numbers: ASD2
U1111-1179-2213 ( Other Identifier: WHO )
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease