I50
Conditions
Interventions
Group 1: The clinical trial should be completed in 20 patients with a complete follow-up. All patients have a primary or secondary prevention indication for ICD / CRT-D implantation according to the c
Sponsors
Otto-von-Guericke Universität Magdeburg, Medizinsiche Fakultät
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with indication for implantation of an ICD / CRT-D according to guidelines, Patients with sinus rhythm or patients with paroxysmal atrial fibrillation, Suitability for follow-up visits, First implantation without a previous ICD / CRT-D system, Patient is able to use CardioMessenger® including Home Monitoring®, Signed declaration of consent.
Exclusion criteria
Exclusion criteria: Patients with permanent atrial fibrillation, Brugada syndrome, Long and short QT syndrome, COPD stages according to GOLD 3 to 4, Life expectancy less than 6 months, Patients who need permanent atrial stimulation Age <18 years, At the same time participants in another clinical trial, Pregnancy or breastfeeding, State according to HTX, Chronic renal failure patients with stage 4 and 5, Patients with active tumor diseases under chemotherapy / radiation therapy, Therapy with local corticosteroid therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confidence intervals of the sensitivities and specificities of the different trained classifiers for the assignment day / night and rest / active when using the ECG data series for each patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) reference range of the differences of the HRV parameters calculated at the same time interval from ECG and ICD data series for each patient, 2) confidence interval of the percentage agreement of the sympathetic and parasympathetic activity calculated for the same patient at the same time interval, 3) Descriptive statistics of the recorded faults. | — |
Countries
Germany
Contacts
Public ContactKerstin Schäfer
Universitätsklinik für Kardiologie und Angiologie
Outcome results
None listed