Heart Diseases
Conditions
Keywords
Sensing, Capture Management, Heart Failure, ICD Indication
Brief summary
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.
Detailed description
The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.
Interventions
DEVICEImplantable Cardioverter Defibrillator
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device * Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.
Exclusion criteria
* Patients who have 3rd degree heart block, as assessed by the investigator * Patients who have a mechanical tricuspid heart valve * Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventricular fibrillation (VF) detection time | — |
| Ventricular Capture Management accuracy | — |
Countries
United States
Outcome results
None listed