Cardiomyopathy Heart Failure
Conditions
Interventions
None listed
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • CRT-D conventional indication • QRS width > 120 ms • Left Ventricular Ejection Fraction (LVEF)
Exclusion criteria
Exclusion criteria: • History of chronic AF • MI within the last 3 Months • Previous pacemaker or ICD implanted • Claudication intermittens or other significant arterial vein issues in the aortic-iliac route • Moderate to severe aortic valve stenosis or indication for valve surgery or mechanical aortic valve replacement or thrombus in Left Ventricle • Age 80 years • Heart failure NYHA class IV • Serious comorbidity such as cancer, with a likelihood of death during the study • Unwilling or unable to sign the consent form for participation • Females of childbearing age not using medically prescribed contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal position of the lead is defined as the one providing optimal acute hemodynamics (defined by the highest Stroke Volume as measured by Pressure-Volume recordings compared to Atrial paced-Ventricle sensed pacing configuration) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of the correlation between the electrical activation pattern and Stroke Work. 2. Assessment of the correlation between mechanical delay and electrical delay. The mechanical (resp. electrical) delay will be defined as the maximum delay between the first and the last contracted (resp. activated) area. 3. Assessment of correlation between scar tissue areas and the latest electrical and mechanical activated areas 4. Assessment of correlation between dp/dt & volumes (PV loops recordings) and optimal position of pacing wire 5. Assessment of electrical parameters: correlation between QRS width and electrical activation patterns | — |
Countries
Netherlands
Outcome results
None listed