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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Brighton, Reino Unido, BN2 1ES
- Ainda não está recrutando
- Royal Sussex County Hospital
-
Contato:
- John Silberbauer, Dr.
- Número de telefone: 01273 664943
- E-mail: john.silberbauer@nhs.net
-
Coventry, Reino Unido, CV2 2DX
- Recrutamento
- University Hospitals Coventry and Warwickshire
-
Contato:
- Tarv Dhanjal, Dr.
- Número de telefone: 02476 966400
- E-mail: Tarv.Dhanjal@uhcw.nhs.uk
-
Contato:
- Jaffar Al-Sheikhli, Dr.
- Número de telefone: 024 7696 2415
- E-mail: Jaffar.Al-Sheikhli@uhcw.nhs.uk
-
Middlesbrough, Reino Unido, TS4 3B
- Recrutamento
- The James Cook University Hospital
-
Contato:
- Matthew Bates, Dr.
- Número de telefone: 58229 01642 858229
- E-mail: matthew.bates1@nhs.net
-
Contato:
- Simon James, Dr.
- E-mail: simon.james1@nhs.net
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: VIVO-assisted VT ablation
|
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.
|
|
Sem intervenção: Standard VT Ablation
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total procedural time (minutes)
Prazo: day of procedure
|
the time from first incision (needle to skin) to the removal of the venous/arterial sheaths
|
day of procedure
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Procedure time in VT (minutes)
Prazo: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Mapping time (minutes)
Prazo: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Ablation time (minutes).
Prazo: During VT ablation procedure
|
During VT ablation procedure
|
|
|
Total number of ablation applications
Prazo: During ablation procedure
|
During ablation procedure
|
|
|
Total number of shocks delivered
Prazo: during the VT ablation procedure
|
during the VT ablation procedure
|
|
|
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)
Prazo: during VT ablation procedure
|
during VT ablation procedure
|
|
|
Number of Participants with substrate modification confirmed by remap
Prazo: during the VT ablation procedure
|
during the VT ablation procedure
|
|
|
Total number of ICD/CRTD determined appropriate shock events
Prazo: 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
Prazo: 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
Prazo: day of procedure to 6 months post-procedure
|
day of procedure to 6 months post-procedure
|
|
|
Recognised VT ablation procedural complications
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: at baseline and 6 months
|
EQ-5D-5L
|
at baseline and 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TD660525
- SOC.12/24-25 (Outro identificador: University of Warwick)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .