Acute Subcutaneous Defibrillation

NCT01771172 | Completed Results

• 1 other identifier: ASQ
• Study Type: observational
• Target: 50
• Locations: 5 countries
• Sites: 8

Brief Summary

To assess the defibrillation efficacy of a subcutaneous defibrillation system.

Conditions

Ventricular Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.

  within the first day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (8)

Republican Scientific and Practical Center Cardiology

Minsk, Belarus

Location

Rigshospitalet

Copenhagen, Denmark

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Slovak Medical University

Bratislava, Slovakia, 83348, Slovakia

Location

Dudley Group NHS-Russells Hall Hospital

Dudley, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Southhampton General Hospital

Southhampton, United Kingdom

Location

Results Point of Contact

• Title: Medtronic CRDM Clinical Trial Manager
• Organization: Medtronic, Inc.

[email protected]

763-505-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 18, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 2, 2016
• Results First Posted: December 2, 2016

Record last verified: 2016-10

Locations

BE (1); GB (3); NL (2); SL (1); DK (1)