Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 68
- Locations
- 22
- Primary Endpoint
- Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
Time Frame: 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 Outcomes
- Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).(Month 2)