Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Study Overview
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Brief Summary
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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.

Official Title
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Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracardiac Impedance Measurement<br> | Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Implantable Cardioverter-Defibrillator, Intracardiac Impedance Measurement, Cardiac Resynchronization Therapy, Home Monitoring, Reverse Remodeling