Acute Subcutaneous Defibrillation (ASQ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01771172
First received: January 16, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

To assess the defibrillation efficacy of a subcutaneous defibrillation system.


Condition
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)
  Eligibility

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

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
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 ClinicalTrials.gov identifier: NCT01771172

Contacts
Contact: ASQ Clinical Trial Leader Wood 18006338766 medtronicCRMtrials@medtronic.com

Locations
Slovakia
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
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 20, 2014