Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
NCT01711281 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2015-07-15
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
Interventions
- DEVICE
-
Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
Sponsors & Collaborators
-
Biotronik SE & Co. KG
lead INDUSTRY
Principal Investigators
-
Peter Sogaard, MD, PhD, Prof. · Aalborg University, Aalborg University Hospital
-
Klaus-Jürgen Gutleben, MD, PhD · Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2015-06-30
Countries
- Denmark
- Germany
- Italy
- Netherlands
- Switzerland
Study Locations
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