Ventricular Arrhythmias
Conditions
Brief summary
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. | within the first day |
Countries
Belarus, Denmark, Netherlands, Slovakia, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acute Defibrillation Testing | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Acute Defibrillation Testing |
|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 50 |
| serious Total, serious adverse events | 9 / 50 |
Outcome results
Primary
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
Time frame: within the first day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Defibrillation Testing | Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. | 85.7 percentage of success |