Ventricular TachycardiaEMPIRE-VTNCT05203484
Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease
A study testing Multielecotrde Mapping and Point-by-point mapping in people with Ventricular Tachycardia, run by Helios Health Institute GmbH at 1 site in Germany.
Trial summary
VT ablation is a frequently performed intervention in patients with symptomatic ventricular tachycardia, electrical storm due to monomorphic VT and appropriate ICD shocks, primarily aiming at reducing the burden of complaints, and ICD shocks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Multielecotrde Mapping and Point-by-point mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to 30 Jul 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Symptomatic ventricular tachycardia with/without ICD and underlying ischemic
- No need for coronary revascularisation therapy based on coronary angiography or Cardiac MRI
- Class I or IIa indication for catheter ablation (according to 2015 Guidelines of the European Society of Cardiology for the management of ventricular tachycardias).
- Signed informed consent.
Who cannot join
- Patients with ventricular assist device
- Reversible causes of ventricular tachycardia (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection/acute myocarditis)
- Recent cardiovascular event including myocardial infarction, percutaneous intervention, valve or cardiac bypass surgery
- Previous VT ablation within the last 3 months
- Patients with ventricular tachycardia and known atrial fibrillation with sufficient antiarrhythmic drug therapy regarding rhythm control of atrial fibrillation
- Medical conditions limiting the expected survival to < 1 year
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- On the waiting list for heart transplant.
- Participation in any other randomized controlled trial
- Women of childbearing potential without appropriate contraceptive measures (oral contraceptives, vaginal ring, intrauterine devices, implanon, injections, partner with vasectomy)
- Subjects under legal supervision or guardianship
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease - A Prospective, Randomised Single Centre Trial
VT ablation is a frequently performed intervention in patients with symptomatic ventricular tachycardia, electrical storm due to monomorphic VT and appropriate ICD shocks, primarily aiming at reducing the burden of complaints, and ICD shocks. The recommendations for its use were described in the ESC guideline for ventricular arrhythmias and the prevention of sudden cardiac death. To visualize the arrhythmogenic substrate leading to ventricular tachycardia complex mapping techniques are currently used in clinical routine, including conventional Point-by-Point mapping or Multielectrode Mapping. The latter is associated with shorter Mapping and overall procedure times, while maintaining the same primary endpoint of the procedure itself. The aim of this trial is to validate, whether the reduction of mapping and procedure time is associated with a comparable long-term outcome compared with conventional Point-by-Point mapping.
Read the detailed description
Catheter Ablation in Patient with VT and ischemic heart disease has shown a beneficial effect in terms of VT Recurrence and Quality of life. The short-term outcome of catheter Ablation in Patients with this particular disease is good, but VT recurrence during long-term follow up is as high as 50-70%.
An integral Part of the Ablation procedure is the substance guided Mapping for localisation of low Voltage areas, late diastolic or fractioned potentials, as possible substrate for VT maintenance. These diastolic pathways, which represent slow conducting myocardium, are the major prerequisites for Reentry and thus for ventricular tachycardia.
Commonly these diastolic pathways are found in myocardial scar after infarction. Cardiac MRI can help to visualize these scars. In Patients with non-ischemic cardiomyopathy, the physician has to rely on intraprocedural Mapping and localisation of pathologic signals mentioned above.
In the last few years, the use of Multielectrode Mapping catheters becomes more and more part of complex EP procedures, mainly due to a high spatio temporal resolution, thereby reducing the overall Mapping time while maintaining the same primary endpoint of VT-non-inducibility compared to Point-by-Point Mapping.
There is growing evidence, that Multielectrode Mapping is associated with lesser mapping and procedure time, while generating more elecatroanatomical points (and thus more information regarding the arrhythmogenic substrate, responsible for VT maintenance).
Currently there is considerable uncertainty as to whether the reduced mapping and procedure time of Multielectrode Mapping will have an effect on the recurrence of ventricular tachycardia.
Procedure time of catheter ablation in patients with scar mediated ventricular tachycardia is directly correlated to hospital mortality.
Yet there are no prospective studies, which evaluate the effect of the aforementioned Mapping systems in the recurrence of ventricular tachycardia in comparison to conventional mapping techniques.
The objective of the trial is to demonstrate that Multielectrode Mapping in patients with ventricular tachycardia with structural (on inflammatory) is not inferior to conventional Mapping techniques with respect to VT Recurrence.
- Conditions
- Ventricular Tachycardia
- Being tested
- Multielecotrde Mapping, Point-by-point mapping
- Keywords
- ischemic heart disease, implantable cardioverter-defibrillator, multielectrode mapping, Point-by-Point Mapping
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multielecotrde MappingDevice
Multielectrode Mapping with Pentaray/Octaray
Point-by-point mappingDevice
Point-by-point mapping with QDot
| Study group | Role | What they receive |
|---|---|---|
| Multielectrode mapping | Experimental | Participants assigned to the Multielectrode Mapping arm will undergo VT ablation within 48 hours after baseline evaluation. The Mapping procedure will be performed with either a Pentaray or Octaray catheter (Biosense Webster; each 45 catheters, randomly allocated). Catheter ablation of potential diastolic pathways and Scar homogenisation will be performed with a irrigated 3.5mm tip catheter (QDot; Biosense Webster). Receives: Device: Multielecotrde Mapping |
| Point-by-Point Mapping | Active comparator | Participants assigned to the Point-by-Point Mapping arm will undergo VT ablation within 48 hours after baseline evaluation. The Mapping procedure will be performed with a QDot catheter (Biosense Webster). Catheter ablation of potential diastolic pathways and scar homogenisation will also be performed with the QDot catheter. Receives: Device: Point-by-point mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
VT recurrence
Time to VT-recurrence based ICD Recordings in dependence of the Mapping modality: Multielectrodemapping with Pentaray/Octaray (Biosense webster) or conventional Point-by-Point mapping with QDOT (Biosense webster)
Measured: 12 months
Secondary outcomes (3)
Comparison of intraprocedural data
EAM Points, total mapping and overall procedure time, Mapping quality/accuracy (mapping points used/points acquired), Scar Area, number of RF ablations, RF Ablation time, total fluoroscopy time) in both arms
Measured: directly after procedure
Rate of ICD shocks/therapies in the follow up period
Total number and date of ATPs/ ICD Shocks, measured by the ICD recordings during the follow up visits
Measured: 12 months
VT Burden
Total number of VT episodes recorded by the ICD in the follow up period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Why it stopped: Principal investigator left Heart Center Leipzig.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aarsh Arya, PD, Study chair, leipzig heart centreGerhard Hindricks, Prof. Dr., Study chair, leipzig heart centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203484
- Sponsor's protocol ID
- EMPIRE-VT
- Acronym
- EMPIRE-VT
- Status last verified
- Aug 2022
- First submitted
- 29 Nov 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease - A Prospective, Randomised Single Centre Trial
- ClinicalTrials.gov ID
- NCT05203484
- Acronym / sponsor ID
- EMPIRE-VT / EMPIRE-VT
- Conditions
- Ventricular Tachycardia
- Keywords
- ischemic heart disease, implantable cardioverter-defibrillator, multielectrode mapping, Point-by-Point Mapping
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Principal investigator left Heart Center Leipzig.
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 24 Jan 2022 (actual)
- 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.
VT ablation is a frequently performed intervention in patients with symptomatic ventricular tachycardia, electrical storm due to monomorphic VT and appropriate ICD shocks, primarily aiming at reducing the burden of complaints, and ICD shocks. The recommendations for its use were described in the ESC guideline for ventricular arrhythmias and the prevention of sudden cardiac death. To visualize the arrhythmogenic substrate leading to ventricular tachycardia complex mapping techniques are currently used in clinical routine, including conventional Point-by-Point mapping or Multielectrode Mapping. The latter is associated with shorter Mapping and overall procedure times, while maintaining the same primary endpoint of the procedure itself. The aim of this trial is to validate, whether the reduction of mapping and procedure time is associated with a comparable long-term outcome compared with conventional Point-by-Point mapping.
Detailed description
Catheter Ablation in Patient with VT and ischemic heart disease has shown a beneficial effect in terms of VT Recurrence and Quality of life. The short-term outcome of catheter Ablation in Patients with this particular disease is good, but VT recurrence during long-term follow up is as high as 50-70%.
An integral Part of the Ablation procedure is the substance guided Mapping for localisation of low Voltage areas, late diastolic or fractioned potentials, as possible substrate for VT maintenance. These diastolic pathways, which represent slow conducting myocardium, are the major prerequisites for Reentry and thus for ventricular tachycardia.
Commonly these diastolic pathways are found in myocardial scar after infarction. Cardiac MRI can help to visualize these scars. In Patients with non-ischemic cardiomyopathy, the physician has to rely on intraprocedural Mapping and localisation of pathologic signals mentioned above.
In the last few years, the use of Multielectrode Mapping catheters becomes more and more part of complex EP procedures, mainly due to a high spatio temporal resolution, thereby reducing the overall Mapping time while maintaining the same primary endpoint of VT-non-inducibility compared to Point-by-Point Mapping.
There is growing evidence, that Multielectrode Mapping is associated with lesser mapping and procedure time, while generating more elecatroanatomical points (and thus more information regarding the arrhythmogenic substrate, responsible for VT maintenance).
Currently there is considerable uncertainty as to whether the reduced mapping and procedure time of Multielectrode Mapping will have an effect on the recurrence of ventricular tachycardia.
Procedure time of catheter ablation in patients with scar mediated ventricular tachycardia is directly correlated to hospital mortality.
Yet there are no prospective studies, which evaluate the effect of the aforementioned Mapping systems in the recurrence of ventricular tachycardia in comparison to conventional mapping techniques.
The objective of the trial is to demonstrate that Multielectrode Mapping in patients with ventricular tachycardia with structural (on inflammatory) is not inferior to conventional Mapping techniques with respect to VT Recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multielectrode mapping | Experimental | Device: Multielecotrde MappingParticipants assigned to the Multielectrode Mapping arm will undergo VT ablation within 48 hours after baseline evaluation. The Mapping procedure will be performed with either a Pentaray or Octaray catheter (Biosense Webster; each 45 catheters, randomly allocated). Catheter ablation of potential diastolic pathways and Scar homogenisation will be performed with a irrigated 3.5mm tip catheter (QDot; Biosense Webster). |
| Point-by-Point Mapping | Active comparator | Device: Point-by-point mappingParticipants assigned to the Point-by-Point Mapping arm will undergo VT ablation within 48 hours after baseline evaluation. The Mapping procedure will be performed with a QDot catheter (Biosense Webster). Catheter ablation of potential diastolic pathways and scar homogenisation will also be performed with the QDot catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Symptomatic ventricular tachycardia with/without ICD and underlying ischemic
- No need for coronary revascularisation therapy based on coronary angiography or Cardiac MRI
- Class I or IIa indication for catheter ablation (according to 2015 Guidelines of the European Society of Cardiology for the management of ventricular tachycardias).
- Signed informed consent.
Key exclusion criteria (11 listed)
- Patients with ventricular assist device
- Reversible causes of ventricular tachycardia (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection/acute myocarditis)
- Recent cardiovascular event including myocardial infarction, percutaneous intervention, valve or cardiac bypass surgery
- Previous VT ablation within the last 3 months
- Patients with ventricular tachycardia and known atrial fibrillation with sufficient antiarrhythmic drug therapy regarding rhythm control of atrial fibrillation
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 |
|---|---|---|
| Multielecotrde MappingMultielectrode Mapping with Pentaray/Octaray | Device | Multielectrode mapping |
| Point-by-point mappingPoint-by-point mapping with QDot | Device | Point-by-Point Mapping |
Primary outcome
VT recurrence
Time frame: 12 months
Time to VT-recurrence based ICD Recordings in dependence of the Mapping modality: Multielectrodemapping with Pentaray/Octaray (Biosense webster) or conventional Point-by-Point mapping with QDOT (Biosense webster)
3 secondary outcomes
Comparison of intraprocedural data
Time frame: directly after procedure
Rate of ICD shocks/therapies in the follow up period
Time frame: 12 months
VT Burden
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Yes
Related trials for Ventricular Tachycardia
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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.
Aarsh Arya, PD study chair
leipzig heart centre
Gerhard Hindricks, Prof. Dr. study chair
leipzig heart centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multielecotrde Mapping and Point-by-point mapping in people with Ventricular Tachycardia, run by Helios Health Institute GmbH 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 5 inclusion and 11 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: paused, as of the sponsor's last update on 19 Aug 2022. 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?
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?
VT recurrence (time frame: 12 months). 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 19 Aug 2022.