Fibrillation, Ventricular, Implantable Cardioverter Defibrillator (ICD), Syncope, Tachycardia, Ventricular
Conditions
Keywords
Implantable cardioverter defibrillator (ICD), Sudden Cardiac Death, Primary Prevention
Brief summary
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac Resynchronozation Therapy) device. The information learned from this study could be used to guide physicians in future ICD or CRT device programming.
Interventions
DEVICEImplanted Device
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient is a candidate for a non-replacement Medtronic ICD device from the Marquis family or has had a non-replacement Medtronic Marquis based ICD system implanted within the previous 6 months and has not had any appropriately treated spontaneous VT/VF episodes during that time.
Exclusion criteria
Patient has history of spontaneous sustained symptomatic ventricular arrhythmias. If patient has had an electrophysiology test in the past, and has sustained inducible VT \<180 bpm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate that patients programmed using a prescribed set of parameters have a lower rate of cardiac syncope, symptoms of fast heart rate, VT/VF events and cardioversion or defibrillation shocks compared to patients programmed per physician discretion | — |
Secondary
| Measure | Time frame |
|---|---|
| characterize the true incidence of VT/VF detections | — |
| therapy efficacy | — |
| time to first inappropriate VT/VF detection | — |
| Evaluate the percentage of inappropriate VT/VF detections | — |
| programming changes | — |
| deaths and cardiovascular adverse event | — |
| incidence of untreated but monitored VT | — |
Countries
Puerto Rico, United States
Outcome results
None listed