Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Heart Failure Clinical Trial

— BIODetectHFII  

Official title:

Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711281
• Other study ID #: CR010
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2012
• Last updated: July 14, 2015
• Start date: October 2012

Study information

• Verified date: July 2015
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)

Locations

Country	Name	City	State
Denmark	Aalborg Sygehus, Kardiologisk Afdeling	Aalborg
Denmark	Aarhus Universitetshospital, Hjertemedicinsk Afdeling B	Aarhus
Denmark	Gentofte Hospital, Department P	Hellerup
Denmark	Odense University Hospital, Hjertemedicinsk Afdeling B	Odense
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie	Berlin
Germany	Herzzentrum Brandenburg, Immanuel Klinikum	Bernau
Germany	Evangelisches Krankenhaus	Bielefeld
Germany	Klinikum Bielefeld Mitte	Bielefeld
Germany	Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen	Essen
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
Italy	Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi	Ancona
Italy	Fondazione Toscana G. Monasterio	Pisa
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology	Zwolle
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).	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.	Month 2	No
Primary	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	No
Secondary	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	No