Heart Failure
Conditions
Keywords
Heart Failure, Implantable Cardioverter-Defibrillator, Intracardiac Impedance Measurement, Cardiac Resynchronization Therapy, Home Monitoring, Reverse Remodeling
Brief summary
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.
Interventions
DEVICEIntracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* De novo CRT-patients * Planned implantation with a Lumax 740 HF-T device, a bipolar LV-lead and a true bipolar RV-lead * NYHA class II or III * QRS ≥ 150 ms * LVEF between 15% and 35% * LVEDD ≥ 55 mm * Evaluable echo measurements
Exclusion criteria
* Persistent or permanent atrial fibrillation * Heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation * Non-ambulatory patients * Chronic renal dialysis * Life expectancy less than 1 year due to a non-cardiac disease * Age \< 18 years and/or limited contractual capability * Addiction to alcohol, medical drugs or illegal drugs * Pregnant or breast-feeding women * Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ). | Month 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ). | Month 2 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ). | Month 2 | 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. |
Countries
Denmark, Germany, Italy, Netherlands, Switzerland
Outcome results
None listed