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OpenTrials
Completed

NCT Number: NCT01711281

Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg Sygehus, Kardiologisk Afdeling, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. 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

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

    Time frame: 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.

Other outcomes

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

    Time frame: Month 2

    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.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Acronym: BIODetectHFII

Important dates

Study start
2012
Primary completion
2015
First posted
Oct 22, 2012
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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