Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia (UNITE-VT)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Brighton, Reino Unido, BN2 1ES
- Aún no reclutando
- Royal Sussex County Hospital
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Contacto:
- John Silberbauer, Dr.
- Número de teléfono: 01273 664943
- Correo electrónico: john.silberbauer@nhs.net
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Coventry, Reino Unido, CV2 2DX
- Reclutamiento
- University Hospitals Coventry and Warwickshire
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Contacto:
- Tarv Dhanjal, Dr.
- Número de teléfono: 02476 966400
- Correo electrónico: Tarv.Dhanjal@uhcw.nhs.uk
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Contacto:
- Jaffar Al-Sheikhli, Dr.
- Número de teléfono: 024 7696 2415
- Correo electrónico: Jaffar.Al-Sheikhli@uhcw.nhs.uk
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Middlesbrough, Reino Unido, TS4 3B
- Reclutamiento
- The James Cook University Hospital
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Contacto:
- Matthew Bates, Dr.
- Número de teléfono: 58229 01642 858229
- Correo electrónico: matthew.bates1@nhs.net
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Contacto:
- Simon James, Dr.
- Correo electrónico: simon.james1@nhs.net
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: VIVO-assisted VT ablation
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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.
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Sin intervención: Standard VT Ablation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total procedural time (minutes)
Periodo de tiempo: day of procedure
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the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
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day of procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Procedure time in VT (minutes)
Periodo de tiempo: during VT ablation procedure
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during VT ablation procedure
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Mapping time (minutes)
Periodo de tiempo: during VT ablation procedure
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during VT ablation procedure
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Ablation time (minutes).
Periodo de tiempo: During VT ablation procedure
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During VT ablation procedure
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Total number of ablation applications
Periodo de tiempo: During ablation procedure
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During ablation procedure
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Total number of shocks delivered
Periodo de tiempo: during the VT ablation procedure
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during the VT ablation procedure
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Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Periodo de tiempo: during VT ablation procedure
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during VT ablation procedure
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Number of Participants with substrate modification confirmed by remap
Periodo de tiempo: during the VT ablation procedure
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during the VT ablation procedure
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Total number of ICD/CRTD determined appropriate shock events
Periodo de tiempo: day of procedure to 6 months post-procedure
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Total number of ICD/CRTD shock events per patient will be documented on database
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day of procedure to 6 months post-procedure
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Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events
Periodo de tiempo: day of procedure to 6 months post-procedure
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Total number of ICD/CRTD ATP events per patient will be documented on database
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day of procedure to 6 months post-procedure
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Total number of VT episodes as determined from ICD/CRTD
Periodo de tiempo: day of procedure to 6 months post-procedure
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day of procedure to 6 months post-procedure
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Recognised VT ablation procedural complications
Periodo de tiempo: day of the procedure to 30 days after the VT ablation procedure
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day of the procedure to 30 days after the VT ablation procedure
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Total number of hospitalisations
Periodo de tiempo: day of the procedure to 30 days after the VT ablation procedure
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Total number of hospitalisation events per patient will be documented on database
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day of the procedure to 30 days after the VT ablation procedure
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Mortality
Periodo de tiempo: day of the procedure to 30 days after the VT ablation procedure
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day of the procedure to 30 days after the VT ablation procedure
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Perceived health benefit of treatment
Periodo de tiempo: at baseline and 6 months
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EQ-5D-5L
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at baseline and 6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TD660525
- SOC.12/24-25 (Otro identificador: University of Warwick)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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