Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmias, Cardiac
- Sponsor
- Medtronic BRC
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change in hemodynamic state during all tachycardia
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Change in hemodynamic state during SVT(<3 hours)