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Acute Subcutaneous Defibrillation (ASQ)

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: NCT01771172
Recruitment Status : Completed
First Posted : January 18, 2013
Results First Posted : December 2, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief Summary:
To assess the defibrillation efficacy of a subcutaneous defibrillation system.

Condition or disease
Ventricular Arrhythmias

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. [ Time Frame: within the first day ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects may be either male or female, and must meet all of the inclusion criteria and none of the exclusion criteria of the study
Criteria

Inclusion Criteria:

  • Subject must be undergoing implant of a commercially approved ICD system
  • Subject must be willing to provide Informed Consent
  • Subject must be > 18 years old

Exclusion Criteria:

  • Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months)
  • Subject has high risk of infection
  • Subject has EF < 15%
  • Subject at high risk of stroke
  • having a device replacement
  • Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
  • Subject is indicated for CRT
  • Subject is pacemaker dependent
  • Subject enrolled in a concurrent study that may confound the results of this study
  • Subject has medical conditions that would limit study participation
  • Subject is pregnant
  • Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
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): NCT01771172


Locations
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Belarus
Republican Scientific and Practical Center Cardiology
Minsk, Belarus
Denmark
Rigshospitalet
Copenhagen, Denmark
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus MC
Rotterdam, Netherlands
Slovakia
Slovak Medical University
Bratislava, Slovakia, 83348
United Kingdom
Dudley Group NHS-Russells Hall Hospital
Dudley, United Kingdom
King's College Hospital
London, United Kingdom
Southhampton General Hospital
Southhampton, United Kingdom
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: NCT01771172    
Other Study ID Numbers: ASQ
First Posted: January 18, 2013    Key Record Dates
Results First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes