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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arrhythmias, Cardiac Procedure: High rate atrial and vetricular stimulation Procedure: Ventricular Tachycardia induction Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Germany
Universitätsklinikum
Aachen, Germany, 52074
Sponsors and Collaborators
Medtronic BRC
Investigators
Principal Investigator: Emilia Stegemann, Dr. med Universitätsklinikum Aachen
More Information
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Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT01088308     History of Changes
Other Study ID Numbers: TPS1010
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes