Acute Subcutaneous Defibrillation (ASQ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2013 by Medtronic Cardiac Rhythm and Heart Failure.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure 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

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 and Heart Failure
  More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure 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 processed this record on May 01, 2016