Acute Subcutaneous Defibrillation (ASQ)

This study is currently recruiting participants.
Verified May 2013 by Medtronic Cardiac Rhythm Disease Management
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management Identifier:
First received: January 16, 2013
Last updated: May 16, 2013
Last verified: May 2013

To assess the defibrillation efficacy of a subcutaneous defibrillation system.

Ventricular Arrhythmias

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Subjects will demonstrate a successful defibrillation outcome if they have 2 successful defibrillation shocks with the research system. [ Time Frame: within the first day ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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


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
Please refer to this study by its identifier: NCT01771172

Contact: ASQ Clinical Trial Leader Wood 18006338766

Slovak Medical University Recruiting
Bratislava, Slovakia, 83348
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management Identifier: NCT01771172     History of Changes
Other Study ID Numbers: ASQ
Study First Received: January 16, 2013
Last Updated: May 16, 2013
Health Authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Ministry of Health, Welfare and Sport
Belarus: Ministry of Health

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 17, 2014