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Dynamic Voltage Mapping to Personalise the Ventricular Tachycardia Substrate (DYNAMITE-VT)

30. april 2026 opdateret af: Liverpool Heart and Chest Hospital NHS Foundation Trust

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder and one of the commonest causes of heart-related sudden death. It often affects people who have had a heart attack or other structural heart damage. VT occurs when abnormal electrical circuits develop within and around scar tissue in the heart.

People at risk are usually offered an implantable cardiac defibrillator (ICD), a device that can detect VT and deliver a lifesaving shock. While effective, these shocks can be sudden, painful and distressing. Medications such as amiodarone can also help, but they are often unsuitable for long-term use due to their potential side effects on the liver, lungs and thyroid gland.

An alternative is catheter ablation. Thin tubes (catheters) are threaded from a blood vessel in the groin to the heart, allowing the cardiologist to identify scar tissue and abnormal electrical circuits, which can be destroyed using heat, freezing or electrical energy.

Although ablation can help many patients, VT can return in up to one in three people after the procedure. This is because it can be difficult to precisely identify the scar and surrounding tissue that sustain the abnormal circuits, making it challenging to know exactly where to apply ablation treatment.

Dynamic Voltage Mapping, is a technique which the investigators believe can more accurately identify scar and the critical bordering tissue during ablation. Initial data collected suggests that the approach accurately predicts the VT circuit and helps guide ablation.

In this study, the investigators wish to recruit 40 participants undergoing VT ablation to determine how effective Dynamic Voltage Mapping is in real-world procedures.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

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
      • Liverpool, Det Forenede Kongerige, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Vishal Luther, MRCP PhD ECES ECDS
        • Underforsker:
          • Justin Chiong, MBChB MSc MRCP

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:

  • Scheduled for clinically indicated VT ablation (due to sustained VT episodes or ICD therapies).
  • Willing and able to give informed consent for participation in the trial
  • Male or female aged between 18-85
  • Ischaemic and non-ischaemic cardiomyopathy
  • ICD insitu

Exclusion Criteria:

  • Unable or unwilling to consent
  • NYHA Class IV (end stage heart failure)
  • Metastatic cancer
  • End stage renal disease
  • Pregnant or breast feeding
  • Severe frailty

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dynamic Voltage Mapping Guided Ablation
Patients assigned to this group will have Dynamic Voltage Maps available for the operator to view during the procedure to help guide ablation.
Procedure: Dynamic Voltage Mapping
Dynamic Voltage Mapping uses electrical information collected from catheters positioned within the heart to create an individualised map of the heart, which the investigators hypothesise will better identify scar and surrounding tissue responsible for ventricular tachycardia.
Andre navne:
  • DVM
  • Dynamic Voltage Map
Aktiv komparator: Standard of Care Ablation
Patients assigned to this group will receive standard of care ablation, and operators will be blinded to Dynamic Voltage Maps created during the procedure.
Procedure: Standard of Care Ablation
Standard catheter ablation of ventricular tachycardia, guided by operator preference
Andre navne:
  • Kateterablation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Study Feasibility
Tidsramme: From enrolment to end of follow up (1 year after procedure)
  1. Proportion of screened patients who were eligible, approached, consented and recruited
  2. Attrition rate: calculated as the total number of recruited patients who withdrew from the study or were lost to follow up
  3. Adherence: calculated as the proportion of recruited participants who were able to fully follow the study protocol in both DVM and standard of care arms during their VT ablation procedure.
From enrolment to end of follow up (1 year after procedure)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedural Time
Tidsramme: From start of procedure to end (skin-to-skin)
Measured in minutes
From start of procedure to end (skin-to-skin)
Ablation time/number of lesions
Tidsramme: From start of procedure to end (skin-to-skin)
Measured by number of ablation lesions applied
From start of procedure to end (skin-to-skin)
Acute VT non-inducibility
Tidsramme: From start of procedure to end (skin-to-skin)
Ability to induce clinical VT at the end of the procedure
From start of procedure to end (skin-to-skin)
VT recurrence Rate
Tidsramme: From end of procedure to end of follow up (12 months)
Number of sustained VT episodes/ICD shocks/therapies following procedure, recorded by implanted cardiac device
From end of procedure to end of follow up (12 months)

Samarbejdspartnere og efterforskere

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

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

3. august 2026

Primær færdiggørelse (Anslået)

1. marts 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 35371
  • FS/CRTF/25/24865 (Andet bevillings-/finansieringsnummer: British Heart Foundation)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in publications (including baseline characteristics, procedural data, and outcome measures). Additional data may be available upon reasonable request, subject to institutional approvals and data sharing agreements.

IPD-delingstidsramme

IPD and supporting information will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.

IPD-delingsadgangskriterier

De-identified individual participant data and supporting documents (study protocol, statistical analysis plan, and analytic code) will be available to qualified researchers for scientifically sound proposals. Access will be granted upon reasonable request to the study's Chief Investigator, subject to review and approval by the sponsor and in accordance with institutional and regulatory requirements. Data will be shared under a formal data sharing agreement, and access will be provided via a secure data transfer method or controlled-access environment.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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