Acute Subcutaneous Defibrillation

Completed

• Conditions: Ventricular Arrhythmias

• Registration Number: NCT01771172
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

To assess the defibrillation efficacy of a subcutaneous defibrillation system.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2016-10
• Results First Submitted: 2016-10-10
• Results First Submitted QC: 2016-10-10
• Last Update Submitted: 2016-10-10
• Results First Posted: 2016-12-02
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.	within the first day

Trial Locations

Locations (8)

Republican Scientific and Practical Center Cardiology; 🇧🇾 Minsk, Belarus

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Slovak Medical University; 🇸🇰 Bratislava, Slovakia

Dudley Group NHS-Russells Hall Hospital; 🇬🇧 Dudley, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Southhampton General Hospital; 🇬🇧 Southhampton, United Kingdom