An observational study in Ventricular Arrhythmias, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 8 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-02.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Observational
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects may be either male or female, and must meet all of the inclusion criteria and none of the exclusion criteria of the study
Exclusion Criteria:
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
Time frame: within the first day
| Milestone | Acute Defibrillation Testing |
|---|---|
| Started | 48 |
| Completed | 46 |
| Not completed | 2 |
| percentage of success | Acute Defibrillation Testing |
|---|---|
| Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. | 85.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acute Defibrillation Testing | — | 9/50 (18%) | 5/50 (10%) |
| Event | Acute Defibrillation Testing |
|---|---|
| Implant site infectionSkin and subcutaneous tissue disorders | 2/50 |
| Post Procedural HematomaBlood and lymphatic system disorders | 2/50 |
| Anaphylactic reactionRespiratory, thoracic and mediastinal disorders | 1/50 |
| Cardiac FailureCardiac disorders | 1/50 |
| Cardiac ArrestCardiac disorders | 1/50 |
| Adverse drug reactionRespiratory, thoracic and mediastinal disorders | 1/50 |
| Ventricular FibrillationCardiac disorders | 1/50 |
| Event | Acute Defibrillation Testing |
|---|---|
| Post Procedural HematomaBlood and lymphatic system disorders | 5/50 |
| Age, Continuous(years) | Acute Defibrillation Testing |
|---|---|
| Mean | 57.7 ± 12.3 |
| Sex: Female, Male(Participants) | Acute Defibrillation Testing |
|---|---|
| Female | 12 |
| Male | 38 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure