Trial Outcomes & Findings for Acute Subcutaneous Defibrillation (NCT NCT01771172)

Last Updated: 2016-12-02

Results Overview

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

within the first day

Results posted on

2016-12-02

Participant milestones
Measure	Acute Defibrillation Testing
Overall Study STARTED	48
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	2

Withdrawal data not reported

Acute Subcutaneous Defibrillation

Baseline characteristics by cohort
Measure	Acute Defibrillation Testing n=50 Participants
Age, Continuous	57.7 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

Timeframe: within the first day

Outcome measures
Measure	Acute Defibrillation Testing n=35 Participants
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.	85.7 percentage of success

Serious events: 9 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	Acute Defibrillation Testing n=50 participants at risk
Skin and subcutaneous tissue disorders Implant site infection	4.0% 2/50 • Number of events 2
Blood and lymphatic system disorders Post Procedural Hematoma	4.0% 2/50 • Number of events 2
Respiratory, thoracic and mediastinal disorders Anaphylactic reaction	2.0% 1/50 • Number of events 1
Cardiac disorders Cardiac Failure	2.0% 1/50 • Number of events 1
Cardiac disorders Cardiac Arrest	2.0% 1/50 • Number of events 1
Respiratory, thoracic and mediastinal disorders Adverse drug reaction	2.0% 1/50 • Number of events 1
Cardiac disorders Ventricular Fibrillation	2.0% 1/50 • Number of events 1

Other adverse events
Measure	Acute Defibrillation Testing n=50 participants at risk
Blood and lymphatic system disorders Post Procedural Hematoma	10.0% 5/50 • Number of events 5

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