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.

Study Overview

• Status: Terminated
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Procedure: High rate atrial and vetricular stimulation; Procedure: Ventricular Tachycardia 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: High rate pacing; Procedure: Ventricular Tachycardia induction; A programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle.; Other Names: VT induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemodynamic state during all tachycardia	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	<3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemodynamic state during SVT	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.	<3 hours

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Principal Investigator: Emilia Stegemann, Dr. med, Universitätsklinikum Aachen

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (Estimate): March 17, 2010

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Arrhythmias, Cardiac; Tachycardia
• Other Study ID Numbers: TPS1010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided