Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement (BIODetectHFII)

Biotronik

Status and phase

Completed

Phase 4

Conditions

Heart Failure

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01711281

CR010

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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