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Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Medtronic BRC.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT01088308
First received: March 11, 2010
Last updated: April 19, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Arrhythmias, Cardiac
 Procedure: High rate atrial and vetricular stimulation
Procedure: Ventricular Tachycardia induction

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • Change in hemodynamic state during all tachycardia [ Time Frame: <3 hours ] [ Designated as safety issue: No ]
    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:
  • Change in hemodynamic state during SVT [ Time Frame: <3 hours ] [ Designated as safety issue: No ]
    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.
Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088308

Contacts
Contact: Berthold Stegemann, Ph.D (+31-43) 3566739 berthold.stegemann@medtronic.com
Contact: Vinayakrishnan Rajan, Ph.D (+31-43) 3566719 vinay.rajan@medtronic.com

Locations
Germany
Universitätsklinikum Recruiting
Aachen, Germany, 52074
Principal Investigator: Emilia Stegemann, Dr. med         
Sponsors and Collaborators
Medtronic BRC
Investigators
Principal Investigator: Emilia Stegemann, Dr. med Universitätsklinikum Aachen
  More Information

No publications provided

Responsible Party: Berthold Stegemann, Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01088308     History of Changes
Other Study ID Numbers: TPS1010
Study First Received: March 11, 2010
Last Updated: April 19, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on March 03, 2015