Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

NCT01711281 | Completed Phase 4

• 1 other identifier: CR010
• Study Type: interventional
• Target: 68
• Locations: 5 countries
• Sites: 22

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.

Conditions

Heart Failure

Keywords

Heart Failure; Implantable Cardioverter-Defibrillator; Intracardiac Impedance Measurement; Cardiac Resynchronization Therapy; Home Monitoring; Reverse Remodeling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).

  Month 2

Other Outcomes (1)

• Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).

  Month 2

Study Arms (1)

Intracardiac Impedance Measurement

EXPERIMENTAL

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

Interventions

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

Intracardiac Impedance Measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (22)

Aalborg Sygehus, Kardiologisk Afdeling

Aalborg, DK-9100, Denmark

Location

Aarhus Universitetshospital, Hjertemedicinsk Afdeling B

Aarhus, 8200, Denmark

Location

Gentofte Hospital, Department P

Hellerup, 2900, Denmark

Location

Odense University Hospital, Hjertemedicinsk Afdeling B

Odense, 5000, Denmark

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie

Berlin, 13353, Germany

Location

Herzzentrum Brandenburg, Immanuel Klinikum

Bernau, 16321, Germany

Location

Klinikum Bielefeld Mitte

Bielefeld, 33604, Germany

Location

Evangelisches Krankenhaus

Bielefeld, Bielefeld, Germany

Location

Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen

Essen, 45147, Germany

Location

Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie

Hanover, 30625, Germany

Location

Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie

Mönchengladbach, 41063, Germany

Location

Klinikum der Universität München - Grosshadern

München, 81377, Germany

Location

Havellandklinik Nauen

Nauen, 16461, Germany

Location

Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie

Reinbek, 21465, Germany

Location

Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin

Würzburg, 97080, Germany

Location

Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi

Ancona, 60126, Italy

Location

Fondazione Toscana G. Monasterio

Pisa, 56124, Italy

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015CE, Netherlands

Location

Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology

Zwolle, 8011 JW, Netherlands

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Peter Sogaard, MD, PhD, Prof.

  Aalborg University, Aalborg University Hospital

  STUDY CHAIR

• Klaus-Jürgen Gutleben, MD, PhD

  Herz- und Diabeteszentrum NRW, Bad Oeynhausen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

CH (1); DK (4); NL (3); DE (12); IT (2)