Acute Subcutaneous Defibrillation

Ventricular Arrhythmias Clinical Trial

— ASQ  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01771172
• Other study ID #: ASQ
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2013
• Last updated: May 16, 2013
• Start date: May 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2013
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: ASQ Clinical Trial Leader Wood
• Phone: 18006338766
• Email: medtronicCRMtrials[@]medtronic.com
• Is FDA regulated: No
• Health authority: Serbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlDenmark: Danish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: Ministry of Health, Welfare and SportBelarus: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To assess the defibrillation efficacy of a subcutaneous defibrillation system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ventricular Arrhythmias

Locations

Country	Name	City	State
Slovakia	Slovak Medical University	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects will demonstrate a successful defibrillation outcome if they have 2 successful defibrillation shocks with the research system.		within the first day	No