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NCT Number: NCT07759427

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Sussex County Hospital, Brighton, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.
  • 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.

Treatment and study plan

VIVO-assisted mapping

Device

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.

Primary outcomes

  1. 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

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

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

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

  9. Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events

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

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

  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

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

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

  13. Mortality

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

  14. Perceived health benefit of treatment

    Time frame: at baseline and 6 months

    EQ-5D-5L

Sponsors and collaborators

Lead sponsor

University of Warwick

Other

Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

Registry information

Official study title

Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia: a UK Randomised Controlled Trial

Acronym: UNITE-VT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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