Heart hailure
Conditions
Interventions
The diagnostic ICI sensor will be activated in study context after CRD-D device
implantation in all patients by special release code for measurment of chonic
hemodynamic changes (the ICI data is sen
Sponsors
Biotronik
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients with an indication for CRT-D device implantation according to the opinion of the treating physician who were not implanted with a CRT-device before (de novo CRT-patients only). * Patients being implanted with single and dual chamber ICDs before may be included in the study. * Patients who are planned to be implanted with a BIOTRONIK Lumax740 HF-T device (or successor). * Patients planned to be implanted with a bipolar LV-lead with a minimum distance of 15 mm between tip and ring. * Patients implanted (or planned to be implanted) with a true bipolar RV-lead. * Patients with NYHA class II and III (with both ischemic or non-ischemic etiology or dilative cardiomyopathy as underlying disease) * Patient is willing and able to comply with the CIP and has provided written informed consent. * Patient accepts Home Monitoring concept and has sufficient GSM/GPRS net coverage. * Evaluable echocardiographic measurements. * Patients with LVEF >= 15% and = 55mm * QRS >= 150ms
Exclusion criteria
Exclusion criteria: * Patients with diagnosed persistent or permanent atrial fibrillation. * Patients suffering from aortic valve stenosis or from more than a trace of aortic valve insufficiency patients with aortic valve prosthesis. * Heart surgery performed in the 3 months prior to enrollment or planned for the time of study participation. * PTCA expected within the first 3 months of study participation. * Post-HTX or listed for HTX. * Non-ambulatory patients. * Patients requiring chronic renal dialysis. * Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra-individual correlation coefficient r between stroke volume assessed by echo Doppler aortic velocity- time-integral and stroke impedance assessed by intracardiac impedance measurement in an acute setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Intra-individual correlation coefficient r between LVESV assessed by echo 2D-Biplane Simpson*s method and end-systolic impedance assessed by intracardiac impedance measurement in an acute setting. 2. Intra-individual correlation coefficient r between SV assessed by the Finapres®-method and stroke impedance assessed by intracardiac impedance measurement in an acute setting. | — |
Countries
Netherlands
Outcome results
None listed