Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

Not Applicable

Terminated

• Conditions: Arrhythmias, Cardiac
• Interventions: Procedure: High rate atrial and vetricular stimulation; Procedure: Ventricular Tachycardia induction

• Registration Number: NCT01088308
• Lead Sponsor: Medtronic BRC

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.

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-08
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Ventricular Tachycardia induction	All Patients underwent Intervention.
Single Arm	High rate atrial and vetricular stimulation	All Patients underwent Intervention.

Primary Outcome Measures

Name	Time	Method
Change in hemodynamic state during all tachycardia	<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

Name	Time	Method
Change in hemodynamic state during SVT	<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.

Trial Locations

Locations (1)

Universitätsklinikum; 🇩🇪 Aachen, Germany