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Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia (UNITE-VT)

6. august 2026 opdateret af: University of Warwick

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Brighton, Det Forenede Kongerige, BN2 1ES
        • Ikke rekrutterer endnu
        • Royal Sussex County Hospital
        • Kontakt:
      • Coventry, Det Forenede Kongerige, CV2 2DX
      • Middlesbrough, Det Forenede Kongerige, TS4 3B

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: VIVO-assisted VT ablation
Enhed: VIVO-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.
Ingen indgriben: Standard VT Ablation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total procedural time (minutes)
Tidsramme: day of procedure
the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
day of procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedure time in VT (minutes)
Tidsramme: during VT ablation procedure
during VT ablation procedure
Mapping time (minutes)
Tidsramme: during VT ablation procedure
during VT ablation procedure
Ablation time (minutes).
Tidsramme: During VT ablation procedure
During VT ablation procedure
Total number of ablation applications
Tidsramme: During ablation procedure
During ablation procedure
Total number of shocks delivered
Tidsramme: during the VT ablation procedure
during the VT ablation procedure
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Tidsramme: during VT ablation procedure
during VT ablation procedure
Number of Participants with substrate modification confirmed by remap
Tidsramme: during the VT ablation procedure
during the VT ablation procedure
Total number of ICD/CRTD determined appropriate shock events
Tidsramme: day of procedure to 6 months post-procedure
Total number of ICD/CRTD shock events per patient will be documented on database
day of procedure to 6 months post-procedure
Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events
Tidsramme: day of procedure to 6 months post-procedure
Total number of ICD/CRTD ATP events per patient will be documented on database
day of procedure to 6 months post-procedure
Total number of VT episodes as determined from ICD/CRTD
Tidsramme: day of procedure to 6 months post-procedure
day of procedure to 6 months post-procedure
Recognised VT ablation procedural complications
Tidsramme: day of the procedure to 30 days after the VT ablation procedure
day of the procedure to 30 days after the VT ablation procedure
Total number of hospitalisations
Tidsramme: day of the procedure to 30 days after the VT ablation procedure
Total number of hospitalisation events per patient will be documented on database
day of the procedure to 30 days after the VT ablation procedure
Mortality
Tidsramme: day of the procedure to 30 days after the VT ablation procedure
day of the procedure to 30 days after the VT ablation procedure
Perceived health benefit of treatment
Tidsramme: at baseline and 6 months
EQ-5D-5L
at baseline and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Warwick

Samarbejdspartnere

University Hospitals Coventry and Warwickshire NHS Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. august 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

29. februar 2028

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. august 2026

Først opslået (Faktiske)

12. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TD660525
  • SOC.12/24-25 (Anden identifikator: University of Warwick)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymised participant data will be made available by the Sponsor following official request.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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