Monitoring of hemodynamics in heart failure patients by intracardiac impedance measurement

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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 <= 35%
* LVEDD >= 55mm
* QRS >= 150ms

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 < 1 year due to a noncardiac disease.
* Patient age < 18 years.
* Patient is addicted to alcohol, medical drugs or illegal drugs.
* Limited contractual capability.
* Pregnant or breast-feeding women.
* Participation in another clinical trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Intra-individual correlation coefficient r between stroke volume assessed by<br /><br>echo Doppler aortic velocity- time-integral and stroke impedance assessed by<br /><br>intracardiac impedance measurement in an acute setting.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1.Intra-individual correlation coefficient r between LVESV assessed by echo<br /><br>2D-Biplane Simpson*s method and end-systolic impedance assessed by intracardiac<br /><br>impedance measurement in an acute setting.<br /><br>2. Intra-individual correlation coefficient r between SV assessed by the<br /><br>Finapres®-method and stroke impedance assessed by intracardiac impedance<br /><br>measurement in an acute setting.</p><br>