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Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters, physical capacity and quality of life. A continuous measurement of the left-ventricular volume would provide information about heart performance and could be used for both heart failure monitoring and optimization of CRT-therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracardiac Impedance Measurement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ). | SV will be assessed using Echo Doppler Ao-VTI (Aortic velocity time integral). SZ will be measured in parallel using intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing. | Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ). | LVESV will be assessed using echo Biplane Simpson's method. LVESZ will be measured using the intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ). | SV will be assessed using a non-invasive blood pressure measurement device. SZ will be measured using the intracardiac impedance measurement.The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Sogaard, MD, PhD, Prof. | Aalborg University, Aalborg University Hospital | Study Chair |
| Klaus-Jürgen Gutleben, MD, PhD | Herz- und Diabeteszentrum NRW, Bad Oeynhausen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Sygehus, Kardiologisk Afdeling | Aalborg | DK-9100 | Denmark | |||
| Aarhus Universitetshospital, Hjertemedicinsk Afdeling B |
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| Month 2 |
| Month 2 |
| Aarhus |
| 8200 |
| Denmark |
| Gentofte Hospital, Department P | Hellerup | 2900 | Denmark |
| Odense University Hospital, Hjertemedicinsk Afdeling B | Odense | 5000 | Denmark |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | 32545 | Germany |
| Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie | Berlin | 13353 | Germany |
| Herzzentrum Brandenburg, Immanuel Klinikum | Bernau | 16321 | Germany |
| Klinikum Bielefeld Mitte | Bielefeld | 33604 | Germany |
| Evangelisches Krankenhaus | Bielefeld | Bielefeld | Germany |
| Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen | Essen | 45147 | Germany |
| Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie | Hanover | 30625 | Germany |
| Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie | Mönchengladbach | 41063 | Germany |
| Klinikum der Universität München - Grosshadern | München | 81377 | Germany |
| Havellandklinik Nauen | Nauen | 16461 | Germany |
| Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie | Reinbek | 21465 | Germany |
| Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin | Würzburg | 97080 | Germany |
| Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi | Ancona | 60126 | Italy |
| Fondazione Toscana G. Monasterio | Pisa | 56124 | Italy |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015CE | Netherlands |
| Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology | Zwolle | 8011 JW | Netherlands |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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