Ventricular Tachyarrhythmia's - cardiac rythm disorder
Conditions
Interventions
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study; • Patients whose age is 18 or above, or of legal age to give informed consent specific to national law • Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD). o As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study*. NYHA class should be documented in the last 3 months. • NYHA Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D). NYHA class should be documented in the last 3 months.
Exclusion criteria
Exclusion criteria: • Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician*s discretion) • Enrolled in any other concurrent study. • Inability or refusal to comply with the follow-up schedule • Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days • Patients prescribed to positive airway pressure therapy • A life expectancy of less than 1 year, per physician discretion • Patient in NYHA Class IV during the last 4 weeks • Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Purpose I: For purpose I, the appropriate clinical performance will be assessed by evaluating and documenting: • Sensing, impedance and threshold tests per applicable Reference guide • All adverse events and all Product Experiences • VT/VF detection & conversion if performed at implant or pre-discharge • Spontaneous episode conversion • Wanded and wireless telemetry Performance will be compared with historical data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Purpose II: Changes in mean Daily median respiratory rate (*RR) between event (11-7 days before an index time) and baseline (60-56 days before an index time). | — |
Countries
Netherlands
Outcome results
None listed