Testing Treatment - Non-Invasive Radio Ablation for ventricular tachycardia
Official title: Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial
- Phase 3
- 2 groups
- One site, in Ottawa
- Recruiting
Interventions
- Medical procedure
Control - Catheter Ablation for VT
Currently standard of care involves surgical resection of myocardial scarring in structural heart disease. Imaging is performed to identify culprit areas for ablation, pre procedural imaging involves echocardiography, CT scanning and PET imaging to assess cardiac function, ischemia, inflammation and scarring. Radiofrequency energy is delivered via catheter to the targets and is performed under sedation or anesthesia using multiple catheters placed in the heart while the patient is anticoagulated. A conventional approach will be used advancing multiple catheters via femoral veins and/or arteries under a combination of fluoroscopic, ultrasound and electroanatomic guidance. Ablation targets include an arrhythmogenic focus or the critical isthmus of the VT circuit and/ or substrate identified on preprocedural imaging or low voltage areas, "scar", identified during endocardial mapping. CA procedures for VT are often long, averaging approximately 5 hours .
- Medical procedure
Treatment - Non-Invasive Radio Ablation for VT
Patients undergoing a non-invasive RA procedure for VT similarly require medical stabilization and multimodal imaging prior to treatment. A non-invasive electrophysiology study is performed under light sedation using ECGi mapping. This procedure requires only the placement of an IV cannula for light sedation, uses the ICD to stimulate VT which is mapped in real time using the ECGi mapping system. The multimodal imaging data is digitally fused and combined with the ECGi data to identify the VT circuit(s) and to attain the targets for radio-ablation. This analogue process is performed off-line by a physician team. The treatment plan is sent for alignment on a 4D planning CT performed with breath holding in the radiotherapy suite. Final treatment targets are reviewed by the local treating team and discussed with our collaborators remotely. Thereafter the patient is booked for a 15 minute out-patient radiotherapy treatment performed on a standard linear accelerator.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patient aged ≥55 years of age
- +Cardiomyopathy (Left ventricular ejection fraction ≤ 35% and ICD in situ) AND
- +Recurrent VT events despite previous CA OR
- +VT events requiring intervention and PAINESD score ≥ 15
Exclusion
- −Patients with NYHA Class IV heart failure \&/ or with LVAD in situ
- −Patients not expected to live for more than one year for any reason
- −Patients who have previously received thoracic radiotherapy
- −Patients who are enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → clinical trialInterventional studyA study where participants are given something to see what happens.Read more →
- −Patients who are unable or unwilling to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Patients aged ≤54 years of age
- −Pregnancy (all women of child bearing age and potential will have a negative β-HCG test before enrollment)
- −Breastfeeding
- −Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception (IUD, sterilization, birth controlControl groupThe group a new treatment is measured against.Read more → implant or birth control pill) throughout the study.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives ControlControl groupThe group a new treatment is measured against.Read more → - Catheter Ablation for VT.
Registry label: A: Control
Group B receives Treatment - Non-Invasive Radio Ablation for VT.
Registry label: B: Treatment
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 55 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 244 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 14 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to composite event — measured over 14 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05047198 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Control - Catheter Ablation for VTProcedure
Currently standard of care involves surgical resection of myocardial scarring in structural heart disease. Imaging is performed to identify culprit areas for ablation, pre procedural imaging involves echocardiography, CT scanning and PET imaging to assess cardiac function, ischemia, inflammation and scarring. Radiofrequency energy is delivered via catheter to the targets and is performed under sedation or anesthesia using multiple catheters placed in the heart while the patient is anticoagulated. A conventional approach will be used advancing multiple catheters via femoral veins and/or arteries under a combination of fluoroscopic, ultrasound and electroanatomic guidance. Ablation targets include an arrhythmogenic focus or the critical isthmus of the VT circuit and/ or substrate identified on preprocedural imaging or low voltage areas, "scar", identified during endocardial mapping. CA procedures for VT are often long, averaging approximately 5 hours .
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Treatment - Non-Invasive Radio Ablation for VTProcedure
Patients undergoing a non-invasive RA procedure for VT similarly require medical stabilization and multimodal imaging prior to treatment. A non-invasive electrophysiology study is performed under light sedation using ECGi mapping. This procedure requires only the placement of an IV cannula for light sedation, uses the ICD to stimulate VT which is mapped in real time using the ECGi mapping system. The multimodal imaging data is digitally fused and combined with the ECGi data to identify the VT circuit(s) and to attain the targets for radio-ablation. This analogue process is performed off-line by a physician team. The treatment plan is sent for alignment on a 4D planning CT performed with breath holding in the radiotherapy suite. Final treatment targets are reviewed by the local treating team and discussed with our collaborators remotely. Thereafter the patient is booked for a 15 minute out-patient radiotherapy treatment performed on a standard linear accelerator.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 55 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 55 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 14 days.
The study as a whole is currently expected to finish around 2027-12-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 244 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study compares two arms - the current standard of care catheter ablation for Ventricular Tachycardia compared to stereotactic radiotherapy to non-invasively ablate ventricular tachycardia using a novel non-invasive ECG based body surface mapping technology. This allows investigators to identify ventricular tachycardia circuits to target for subsequent radio ablation. To summarize, the current standard of care invasive catheter ablation to the non-invasive radio ablation.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.