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

30. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
      • Liverpool, Storbritannia, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Vishal Luther, MRCP PhD ECES ECDS
        • Underetterforsker:
          • Justin Chiong, MBChB MSc MRCP

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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 navn:
  • 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.
Fremgangsmåte: Standard of Care Ablation
Standard catheter ablation of ventricular tachycardia, guided by operator preference
Andre navn:
  • Kateterablasjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

3. august 2026

Primær fullføring (Antatt)

1. mars 2029

Studiet fullført (Antatt)

1. august 2029

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 35371
  • FS/CRTF/25/24865 (Annet stipend/finansieringsnummer: British Heart Foundation)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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