Arrhythmias, CardiacNCT01088308
Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
A study testing High rate atrial and vetricular stimulation and Ventricular Tachycardia induction in people with Arrhythmias, Cardiac, run by Medtronic BRC at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- High rate atrial and vetricular stimulation and Ventricular Tachycardia induction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- High rate atrial and vetricular stimulation, Ventricular Tachycardia induction
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High rate atrial and vetricular stimulationProcedure or surgery
Also called High rate pacing
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.
Ventricular Tachycardia inductionProcedure or surgery
Also called VT induction
A programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All Patients underwent Intervention. Receives: Procedure: High rate atrial and vetricular stimulation; Procedure: Ventricular Tachycardia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: <3 hours
Secondary outcomes (1)
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.
Measured: <3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: No enrollements for more than 6 months in Phase II
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilia Stegemann, Dr. med, Principal investigator, Universitätsklinikum Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088308
- Sponsor's protocol ID
- TPS1010
- Status last verified
- Jul 2016
- First submitted
- 11 Mar 2010
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion
- ClinicalTrials.gov ID
- NCT01088308
- Acronym / sponsor ID
- TPS1010
- Conditions
- Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No enrollements for more than 6 months in Phase II
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Procedure: High rate atrial and vetricular stimulation, Procedure: Ventricular Tachycardia inductionAll Patients underwent Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High rate atrial and vetricular stimulationAlso: High rate pacingThe 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. | Procedure or surgery | Single Arm |
| Ventricular Tachycardia inductionAlso: VT inductionA programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle. | Procedure or surgery | Single Arm |
Primary outcome
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
1 secondary outcome
Change in hemodynamic state during SVT
Time frame: <3 hours
Results and safety
The study was stopped early (reason given: No enrollements for more than 6 months in Phase II). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Stegemann, Dr. med principal investigator
Universitätsklinikum Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High rate atrial and vetricular stimulation and Ventricular Tachycardia induction in people with Arrhythmias, Cardiac, run by Medtronic BRC at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No enrollements for more than 6 months in Phase II). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemodynamic state during all tachycardia (time frame: <3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.