Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Biotronik SE & Co. KG68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Aalborg Sygehus, Kardiologisk Afdeling

Aalborg, Denmark

Outcomes

Primary Outcomes

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.

Time frame: Month 2

Secondary Outcomes

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.

Time frame: Month 2

Data from ClinicalTrials.gov

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