Acute Subcutaneous Defibrillation (ASQ)
This study is currently recruiting participants.
Verified May 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Medtronic Cardiac Rhythm Disease Management
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
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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
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 May 16, 2013