A Prospective Non-randomized Multicenter Study to Demonstrate the Clinical Validity of the Intracardiac Impedance (ICI) Measurements by Comparing the ICI Values with Clinical Markers which are Relevant for Efficient Therapy Management of Heart Failure Patient

A Prospective Non-randomized Multicenter Study to Demonstrate the Clinical Validity of the Intracardiac Impedance (ICI) Measurements by Comparing the ICI Values with Clinical Markers which are Relevant for Efficient Therapy Management of Heart Failure Patient - DETECT-ICI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009660

Enrollment

200

Registered

2013-01-01

Start date

2012-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Patient signed patient informed consent form. *Patient has a standard indication for CRT-D therapy. *Patient is implanted a new bipolar LV lead with a tip ring distance of at least *Patient is implanted a true bipolar RV shock lead *Patient accepts Home Monitoring concept and has sufficient 3 G/L-LINE net *Patient is able to attend to the planned *Patient has legal capacity and ability to consent.

Exclusion criteria

Exclusion criteria: *Patient has a standard contraindication for CRT-D implantation. *Permanent AF and contraindication to be programmed to non-DDD mode (DDI or VVI) *Patient suffering from aortic valve stenosis, severe aortic insufficiency, or aortic valve prosthesis *Age < 20 years *Pregnant or breast-feeding woman *Cardiac surgery within previous 3 months or planned at time of inclusion *Life expectancy of less than 12 months due to any condition *Chronic renal dialysis *Participating in a clinical study of an investigational cardiac drug or device that includes an active treatment arm

Design outcomes

Primary

Measure	Time frame
The purpose of the primary endpoint 1 is the evaluation of the correlation between the end-systolic impedance (ESZ) assessed by the intracardiac impedance measurement and the left ventricular end-systolic volume (LVESV) assessed by echo 2 dimensional biplane Simpson's method.	—

Secondary

Measure	Time frame
Identification of a predictive signal pattern of the intracardiac impedance for acute decompensation of heart failure Evaluate the correlation between intracardiac impedance and the expected 1-year survival period calculated by the Seattle Heart Failure score Evaluate the correlation between stroke impedance assessed by the intracardiac impedance measurement and stroke volume assessed by echocardiography Evaluate the correlation between stroke impedance assessed by the intracardiac impedance measurement and the blood concentration of the natriuretic peptide BNP	—

Measure

Time frame

*Identification of a predictive signal pattern of the intracardiac impedance for acute decompensation of heart failure *Evaluate the correlation between intracardiac impedance and the expected 1-year survival period calculated by the Seattle Heart Failure score *Evaluate the correlation between stroke impedance assessed by the intracardiac impedance measurement and stroke volume assessed by echocardiography *Evaluate the correlation between stroke impedance assessed by the intracardiac impedance measurement and the blood concentration of the natriuretic peptide BNP

—

Countries

Japan

Contacts

Public ContactKazuomi Tanaka

Biotronik Japan Clinical Affairs

03-3473-7478

Outcome results