Individualized consideration of circadian rhythms to prevent sudden cardiac death
- Conditions
- I50Heart failure
- Registration Number
- DRKS00022238
- Lead Sponsor
- Otto-von-Guericke Universität Magdeburg, Medizinsiche Fakultät
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 23
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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,<br>2) confidence interval of the percentage agreement of the sympathetic and parasympathetic activity calculated for the same patient at the same time interval,<br>3) Descriptive statistics of the recorded faults.