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RecruitingNCT07759427UNITE-VTUpdated Aug 12, 2026

Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia

An interventional study of VIVO-assisted mapping in Ventricular Tachycardia (VT) and Catheter Ablation, sponsored by University of Warwick. Recruiting at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by University of Warwick · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ventricular Tachycardia (VT)
  • Catheter Ablation

Keywords

  • Ventricular tachycardia
  • VT
  • ablation
  • non-invasive mapping
  • procedural VT duration
  • procedural efficiency
  • clinical outcomes
03

In context

Tachycardia, Ventricular

451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

This study's planned enrollment of 110 is above the median of 71 across 280 interventional studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

University of Warwick is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥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.

Exclusion criteria

Exclusion Criteria:

  • Lacks capacity to provide .
  • 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.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Active comparator
    VIVO-assisted VT ablation

    Device: VIVO-assisted mapping

  • No intervention
    Standard VT Ablation

Interventions

  • DeviceVIVO-assisted mapping

    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.

06

What researchers measure

Primary outcomes

  1. Total procedural time (minutes)

    the time from first incision (needle to skin) to the removal of the venous/arterial sheaths

    Time frame: day of procedure

Secondary outcomes

  1. Procedure time in VT (minutes)

    Time frame: during VT ablation procedure

  2. Mapping time (minutes)

    Time frame: during VT ablation procedure

  3. Ablation time (minutes).

    Time frame: During VT ablation procedure

  4. Total number of ablation applications

    Time frame: During ablation procedure

  5. Total number of shocks delivered

    Time frame: during the VT ablation procedure

  6. Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)

    Time frame: during VT ablation procedure

  7. Number of Participants with substrate modification confirmed by remap

    Time frame: during the VT ablation procedure

  8. Total number of ICD/CRTD determined appropriate shock events

    Total number of ICD/CRTD shock events per patient will be documented on database

    Time frame: day of procedure to 6 months post-procedure

  9. 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

    Time frame: day of procedure to 6 months post-procedure

  10. Total number of VT episodes as determined from ICD/CRTD

    Time frame: day of procedure to 6 months post-procedure

  11. Recognised VT ablation procedural complications

    Time frame: day of the procedure to 30 days after the VT ablation procedure

  12. Total number of hospitalisations

    Total number of hospitalisation events per patient will be documented on database

    Time frame: day of the procedure to 30 days after the VT ablation procedure

  13. Mortality

    Time frame: day of the procedure to 30 days after the VT ablation procedure

  14. Perceived health benefit of treatment

    EQ-5D-5L

    Time frame: at baseline and 6 months

07

Study locations

2 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Anonymised participant data will be made available by the Sponsor following official request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07759427
Lead sponsor
University of Warwick
Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Feb 29, 2028 (estimated)
Last update
Aug 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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