Arrhythmias, Cardiac
Conditions
Brief summary
This research study is a prospective, single-center, feasibility study designed to assess the possibility to detect hemodynamic changes during tachycardia episodes using tissue perfusion.
Detailed description
This study is being conducted to evaluate the feasibility to detect hemodynamic changes induced by supra-ventricular or ventricular tachycardia (SVT or VT) using tissue perfusion. Patients with a standard indication for either an electrophysiological study or an implantable cardioverter defibrillators(ICD) implant can be included into this study. Tissue perfusion and arterial blood pressure will be monitored and recorded throughout the electrophysiological procedure or ICD implant testing. The study will be conducted in two consecutive phases. After completion of study phase I the study phase II will commence. Study phase I will be an acute non-invasive study in patients with an indication for an electrophysiological study, in whom tissue perfusion will be measured non-invasively with an epi-cutaneous tissue perfusion sensor. Phase II will be an acute invasive study in patients with an indication for the implantation of an ICD, in whom the tissue perfusion sensor will be placed in the surgically prepared device pocket on the muscular pectoralis or between the muscular pectoralis major and muscular pectoralis minor.
Interventions
PROCEDUREHigh rate atrial and vetricular stimulation
The right atria and ventricle of the subject will be electrically stimulated at high rate mimicking tachycardia episodes using electrodes placed in the right atria and ventricle.
PROCEDUREVentricular Tachycardia induction
A programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle.
Sponsors
Medtronic BRC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for: an electrophysiological study with ventricular stimulation OR the implantation of an implantable cardioverter defibrillator (ICD) * Patient is at least 18 years old. * Patient is able and willing to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemodynamic state during all tachycardia | <3 hours | The primary objective is to demonstrate for all tachycardia (supra-ventricular and ventricular tachycardia) a 90 % \[two sided confidence interval of 75-100 %\] agreement between the true hemodynamic state (stable or unstable) derived from arterial blood pressure measurement and the hemodynamic state determined by tissue perfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemodynamic state during SVT | <3 hours | The secondary objective is to demonstrate for supra-ventricular tachycardia a 90 % \[two sided confidence interval of 75-100 %\] agreement between the true hemodynamic state (stable or unstable) derived from arterial blood pressure measurement and the hemodynamic state determined by tissue perfusion. |
Countries
Germany
Outcome results
None listed