NCT02227121

Acute Defibrillation Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.

Detailed description

The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure. The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care. Subjects were followed through their routine post-surgery follow-up visit. At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.

Conditions

• Ventricular Arrhythmias

Interventions

Type	Name	Description
DEVICE	Defibrillation following induction of VT/VF	Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2014-08-27
• Last updated: 2017-02-13
• Results posted: 2017-02-13

Locations

7 sites across 4 countries: Hong Kong, Netherlands, Poland, United Kingdom