NCT01088308

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

March 11, 2010

Last Update Submit

July 8, 2016

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in hemodynamic state during SVT

    <3 hours

Study Arms (1)

Single Arm

EXPERIMENTAL

All Patients underwent Intervention.

Procedure: High rate atrial and vetricular stimulationProcedure: Ventricular Tachycardia induction

Interventions

High rate atrial and vetricular stimulationPROCEDURE

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.

Also known as: High rate pacing
Single Arm
Ventricular Tachycardia inductionPROCEDURE

A programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle.

Also known as: VT induction
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emilia Stegemann, Dr. med

    Universitätsklinikum Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 17, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

DE(1)