Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)

• Registration Number: NCT01711281
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intracardiac Impedance Measurement	Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (22)

Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie; 🇩🇪 Berlin, Germany

Klinikum Bielefeld Mitte; 🇩🇪 Bielefeld, Germany

Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie; 🇩🇪 Hannover, Germany

Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie; 🇩🇪 Mönchengladbach, Germany

Klinikum der Universität München - Grosshadern; 🇩🇪 München, Germany

Havellandklinik Nauen; 🇩🇪 Nauen, Germany

Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie; 🇩🇪 Reinbek, Germany

Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin; 🇩🇪 Würzburg, Germany

Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi; 🇮🇹 Ancona, Italy

Fondazione Toscana G. Monasterio; 🇮🇹 Pisa, Italy

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology; 🇳🇱 Zwolle, Netherlands

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland

Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen; 🇩🇪 Essen, Germany

Gentofte Hospital, Department P; 🇩🇰 Hellerup, Denmark

Odense University Hospital, Hjertemedicinsk Afdeling B; 🇩🇰 Odense, Denmark

Herzzentrum Brandenburg, Immanuel Klinikum; 🇩🇪 Bernau, Germany

Aarhus Universitetshospital, Hjertemedicinsk Afdeling B; 🇩🇰 Aarhus, Denmark

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Aalborg Sygehus, Kardiologisk Afdeling; 🇩🇰 Aalborg, Denmark

Evangelisches Krankenhaus; 🇩🇪 Bielefeld, Germany

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands