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Acute Subcutaneous Defibrillation (ASQ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771172
First Posted: January 18, 2013
Last Update Posted: December 2, 2016
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.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
  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

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01771172     History of Changes
Other Study ID Numbers: ASQ
First Submitted: January 16, 2013
First Posted: January 18, 2013
Results First Submitted: October 10, 2016
Results First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: October 2016