Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
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|ClinicalTrials.gov Identifier: NCT01088308|
Recruitment Status : Terminated (No enrollements for more than 6 months in Phase II)
First Posted : March 17, 2010
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Arrhythmias, Cardiac||Procedure: High rate atrial and vetricular stimulation Procedure: Ventricular Tachycardia induction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Single Arm
All Patients underwent Intervention.
Procedure: High 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.
Other Name: High rate pacing
Procedure: Ventricular Tachycardia induction
A programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle.
Other Name: VT induction
- Change in hemodynamic state during all tachycardia [ Time Frame: <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
- Change in hemodynamic state during SVT [ Time Frame: <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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088308
|Aachen, Germany, 52074|
|Principal Investigator:||Emilia Stegemann, Dr. med||Universitätsklinikum Aachen|