Ventricular Tachycardia (VT)UNITE-VTNCT07759427
Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia
A study testing VIVO-assisted mapping in people with Ventricular Tachycardia (VT) and Catheter Ablation, run by University of Warwick at 3 sites in United Kingdom.
Trial summary
Ventricular tachycardia (VT) is an abnormal and dangerous heart rhythm affecting the lower chambers of the heart (the ventricles). Patients with structural heart disease caused by previous heart attacks are at an increased risk of developing VT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT), Catheter Ablation
- What is being tested?
- VIVO-assisted mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 15 Aug 2026to 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years old
- Patient with the following:
- Evidence of post-myocardial infarction* structural heart disease.
- Cardiac CT and/or cardiac MRI scan performed within 6 months.
- ICD/CRTD implantation.
- Device therapy for VT: at least 1 appropriate ICD shock or 3 ATP episodes within a 6-month period.
- Suitable candidate for VT ablation as per NHS standard of care.
- Patient agrees to comply with study procedures and be available for routine follow up visits for at least 6 months after enrolment.
Who cannot join
- Lacks capacity to provide informed consent.
- Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
- Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
- Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.
- Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the patient or deem the patient inappropriate to participate in the study.
- Known allergies or intolerance to AADs to be used to treat PVCs.
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- Known allergy for contrast.
- Female patients who are pregnant or breast feeding.
- Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem them inappropriate to participate in this study.
- Other conditions that may prevent patients from adhering to the study protocol, in the opinion of the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Royal Sussex County Hospital
Brighton, BN2 1ES
John Silberbauer, Dr., 01273 664943, john.silberbauer@nhs.net
- Recruiting
University Hospitals Coventry and Warwickshire
Coventry, CV2 2DX
Tarv Dhanjal, Dr., 02476 966400, Tarv.Dhanjal@uhcw.nhs.uk
Jaffar Al-Sheikhli, Dr., 024 7696 2415, Jaffar.Al-Sheikhli@uhcw.nhs.uk
- Recruiting
The James Cook University Hospital
Middlesbrough, TS4 3B
Matthew Bates, Dr., 01642 858229 ext. 58229, matthew.bates1@nhs.net
Simon James, Dr., simon.james1@nhs.net
About this study
Official title: Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia: a UK Randomised Controlled Trial
Ventricular tachycardia (VT) is an abnormal and dangerous heart rhythm affecting the lower chambers of the heart (the ventricles). Patients with structural heart disease caused by previous heart attacks are at an increased risk of developing VT. Current guidelines recommend that patients who develop this abnormal heart rhythm are considered for invasive catheter ablation (ICA). This is an invasive procedure where specialised catheters and a 3D electro anatomical mapping (EAM) system are used to identify the region of the heart responsible for the VT, which is then treated by tissue heating or freezing (ablation). Although significant improvements have been made in both mapping and ablation technologies, these procedures remain technically challenging and time consuming.
View into ventricular onset (VIVO, Catheter Precision) is a non-invasive, mapping system already being used within the NHS. It uses images from previous heart scans, a picture of the patient's chest (taken at the start of the procedure) and a 12-lead electrocardiogram (ECG) tracing, to locate where the VT is coming from. The VIVO map can therefore highlight the likely region of interest for ICA prior to invasive EAM.
This study will be a prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT). Patients will be evenly randomised (50:50) into a standard VT ablation group and a VIVO guided ablation group. In the VIVO guided ablation group, invasive EAM will be restricted to the region of interest identified using the VIVO map, rather than whole chamber mapping required for standard ablation. The primary objective will be to determine if the VIVO non-invasive mapping system reduces procedure duration and therefore improves workflow efficiency. Secondary objectives will assess the procedural success, safety and patient perceived health benefits of a VIVO guided ablation versus standard ablation.
- Conditions
- Ventricular Tachycardia (VT), Catheter Ablation
- Being tested
- VIVO-assisted mapping
- Keywords
- Ventricular tachycardia, VT, ablation, non-invasive mapping, procedural VT duration, procedural efficiency, clinical outcomes
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVO-assisted mappingDevice
VIVO (or View Into Ventricular Onset) is a non-invasive cardiac mapping technology which uses images from patients' previous heart scans, a picture of their chest (taken at the start of the procedure) and a tracing of their VT, to locate where the ventricular tachycardia is coming from.
| Study group | Role | What they receive |
|---|---|---|
| VIVO-assisted VT ablation | Active comparator | Not described Receives: Device: VIVO-assisted mapping |
| Standard VT Ablation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedural time (minutes)
the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
Measured: day of procedure
Secondary outcomes (14)
Procedure time in VT (minutes)
Measured: during VT ablation procedure
Mapping time (minutes)
Measured: during VT ablation procedure
Ablation time (minutes).
Measured: During VT ablation procedure
Total number of ablation applications
Measured: During ablation procedure
Total number of shocks delivered
Measured: during the VT ablation procedure
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Measured: during VT ablation procedure
Number of Participants with substrate modification confirmed by remap
Measured: during the VT ablation procedure
Total number of ICD/CRTD determined appropriate shock events
Total number of ICD/CRTD shock events per patient will be documented on database
Measured: day of procedure to 6 months post-procedure
Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events
Total number of ICD/CRTD ATP events per patient will be documented on database
Measured: day of procedure to 6 months post-procedure
Total number of VT episodes as determined from ICD/CRTD
Measured: day of procedure to 6 months post-procedure
Recognised VT ablation procedural complications
Measured: day of the procedure to 30 days after the VT ablation procedure
Total number of hospitalisations
Total number of hospitalisation events per patient will be documented on database
Measured: day of the procedure to 30 days after the VT ablation procedure
Mortality
Measured: day of the procedure to 30 days after the VT ablation procedure
Perceived health benefit of treatment
EQ-5D-5L
Measured: at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (VT)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT).
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759427
- Sponsor's protocol ID
- TD660525
- Other IDs
- SOC.12/24-25
- Acronym
- UNITE-VT
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant data will be made available by the Sponsor following official request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia: a UK Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07759427
- Acronym / sponsor ID
- UNITE-VT / TD660525
- Conditions
- Ventricular Tachycardia (VT), Catheter Ablation
- Keywords
- Ventricular tachycardia, VT, ablation, non-invasive mapping, procedural VT duration, procedural efficiency, clinical outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 12 Aug 2026 (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.
Ventricular tachycardia (VT) is an abnormal and dangerous heart rhythm affecting the lower chambers of the heart (the ventricles). Patients with structural heart disease caused by previous heart attacks are at an increased risk of developing VT. Current guidelines recommend that patients who develop this abnormal heart rhythm are considered for invasive catheter ablation (ICA). This is an invasive procedure where specialised catheters and a 3D electro anatomical mapping (EAM) system are used to identify the region of the heart responsible for the VT, which is then treated by tissue heating or freezing (ablation). Although significant improvements have been made in both mapping and ablation technologies, these procedures remain technically challenging and time consuming.
View into ventricular onset (VIVO, Catheter Precision) is a non-invasive, mapping system already being used within the NHS. It uses images from previous heart scans, a picture of the patient's chest (taken at the start of the procedure) and a 12-lead electrocardiogram (ECG) tracing, to locate where the VT is coming from. The VIVO map can therefore highlight the likely region of interest for ICA prior to invasive EAM.
This study will be a prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT). Patients will be evenly randomised (50:50) into a standard VT ablation group and a VIVO guided ablation group. In the VIVO guided ablation group, invasive EAM will be restricted to the region of interest identified using the VIVO map, rather than whole chamber mapping required for standard ablation. The primary objective will be to determine if the VIVO non-invasive mapping system reduces procedure duration and therefore improves workflow efficiency. Secondary objectives will assess the procedural success, safety and patient perceived health benefits of a VIVO guided ablation versus standard ablation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| VIVO-assisted VT ablation | Active comparator | Device: VIVO-assisted mapping |
| Standard VT Ablation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years old
- Patient with the following:
- Suitable candidate for VT ablation as per NHS standard of care.
- Patient agrees to comply with study procedures and be available for routine follow up visits for at least 6 months after enrolment.
Key exclusion criteria (10 listed)
- Lacks capacity to provide informed consent.
- Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
- Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
- Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.
- Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the patient or deem the patient inappropriate to participate in the study.
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 |
|---|---|---|
| VIVO-assisted mappingVIVO (or View Into Ventricular Onset) is a non-invasive cardiac mapping technology which uses images from patients' previous heart scans, a picture of their chest (taken at the start of the procedure) and a tracing of their VT, to locate where the ventricular tachycardia is coming from. | Device | VIVO-assisted VT ablation |
Primary outcome
Total procedural time (minutes)
Time frame: day of procedure
the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
14 secondary outcomes
Procedure time in VT (minutes)
Time frame: during VT ablation procedure
Mapping time (minutes)
Time frame: during VT ablation procedure
Ablation time (minutes).
Time frame: During VT ablation procedure
Total number of ablation applications
Time frame: During ablation procedure
Total number of shocks delivered
Time frame: during the VT ablation procedure
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Time frame: during VT ablation procedure
Number of Participants with substrate modification confirmed by remap
Time frame: during the VT ablation procedure
Total number of ICD/CRTD determined appropriate shock events
Time frame: day of procedure to 6 months post-procedure
Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events
Time frame: day of procedure to 6 months post-procedure
Total number of VT episodes as determined from ICD/CRTD
Time frame: day of procedure to 6 months post-procedure
Recognised VT ablation procedural complications
Time frame: day of the procedure to 30 days after the VT ablation procedure
Total number of hospitalisations
Time frame: day of the procedure to 30 days after the VT ablation procedure
Mortality
Time frame: day of the procedure to 30 days after the VT ablation procedure
Perceived health benefit of treatment
Time frame: at baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymised participant data will be made available by the Sponsor following official request.
Related trials for Ventricular Tachycardia (VT)
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MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
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Not yet recruiting
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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.
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
The James Cook University Hospital
Middlesbrough, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVO-assisted mapping in people with Ventricular Tachycardia (VT) and Catheter Ablation, run by University of Warwick at 3 sites in United Kingdom.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total procedural time (minutes) (time frame: day of procedure). 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 12 Aug 2026.