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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
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

March 11, 2010
March 17, 2010
July 11, 2016
March 2010
May 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01088308 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Arrhythmias, Cardiac
  • 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
Experimental: Single Arm
All Patients underwent Intervention.
Interventions:
  • Procedure: High rate atrial and vetricular stimulation
  • Procedure: Ventricular Tachycardia induction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
30
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01088308
TPS1010
No
Not Provided
Plan to Share IPD: Undecided
Medtronic BRC
Medtronic BRC
Not Provided
Principal Investigator: Emilia Stegemann, Dr. med Universitätsklinikum Aachen
Medtronic BRC
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP