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Radioterapia ablativa estereotáctica para el tratamiento de la taquicardia ventricular refractaria (SABRE-VT)

18 de septiembre de 2026 actualizado por: Barts & The London NHS Trust

Ventricular tachycardia (VT) is an abnormal rhythm arising from the bottom chambers (ventricles) of the heart. The hearts of most patients who develop VT have been previously damaged by a myocardial infarction (heart attack) or other heart muscle diseases (cardiomyopathies). The damage produces scar or fatty deposits that conduct electrical impulses slowly allowing VT to occur. Recurrent episodes of VT can compromise heart function and increase mortality.

VT is prevented by special drugs but these are not always effective and can have many side effects. Most patients with VT will also have a specialised device called an implantable defibrillator (ICD) implanted. The ICD treats VT by either stimulating the heart rapidly or delivering a shock to it. ICDs are very effective but the shocks are painful and have a big impact on quality of life. If VT occurs despite optimal drug treatment, patients undergo an invasive procedure called catheter ablation. Here, wires are passed into the heart from the blood vessels in the leg and the damaged heart muscle causing the VT is identified whilst the heart is in VT. An electrical current is passed down the wire making its tip heat up allowing discrete burns (ablation) to be placed inside the heart. The ablated heart muscle doesn't conduct electricity which stops the VT and prevents it recurring.

Some patients are so frail that ablation cannot be performed safely. A recent clinical trial has shown that VT can be treated in such patients using radiotherapy, which is usually used to treat tumours with high energy radiation. This approach is non-invasive, painless and requires no sedation or anaesthesia.

This study will test whether VT can be successfully treated using stereotactic ablative radiotherapy. This can deliver high dose radiotherapy very precisely, whilst minimising the risk of damage to healthy tissues.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Principal objectives:

1. To determine the safety and efficacy of stereotactic ablative radiotherapy (SABR) for the treatment of VT refractory to conventional therapies.

Background:

VT is an abnormal heart rhythm arising from either of the bottom chambers of the heart (ventricles). Most patients with VT have scarring or fatty deposits in the heart muscle caused by a previous heart attack or a heart muscle problem called a cardiomyopathy. The abnormal heart muscle conducts electricity slowly allowing VT to occur. Most patients with VT have a device called an implantable defibrillator (ICD) fitted to treat VT. The ICD has wires going into the heart from a small generator that is inserted under the skin below the left collar bone. ICDs stop VT by stimulating the heart rapidly or by shocking the heart which is very painful and can stun the heart temporarily, weakening its pumping function. Patients who experience a lot of VT can have more admissions to hospital, worsening heart failure and a poorer quality of life, as well as a higher risk of dying. Consequently, all patients are treated with drugs to prevent VT but these are not always effective. If VT keeps recurring, many patients undergo an invasive procedure called catheter ablation where wires are passed into the heart from the leg and the part of the ventricles causing the VT identified. A high frequency electrical current is then passed down one of the wires making its tip heat up allowing discrete burns (ablation) to be placed on the culprit area, which stops the VT and prevents it from recurring. Performing catheter ablation in such patients is a high risk procedure and the overall complication rate is between 5 - 15% in experienced centres. Some patients have recurrent VT despite catheter ablation or the VT cannot be ablated because the patient is too frail, or the VT causes a significant fall in the blood pressure resulting in cardiac arrest (heart stops beating).

In the last 6 years, several case reports and series have been published showing that radiotherapy using different types of linear accelerator machines (including the Cyberknife) can successfully and safely ablate VT. Most recently, a prospective, randomised trial (ENCORE-VT) has reported a dramatic reduction in VT following radioablation.

This study will therefore assess our ability to perform stereotactic radioablation for VT at St Bartholomew's Hospital. We will determine procedural success and safety. Patients will be assessed 3, 6 and 12 months after the treatment and their burden of VT determined by checking the ICD.

Tipo de estudio

Intervencionista

Inscripción (Actual)

4

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • London, Reino Unido, EC1A 7BE
        • St Bartholomew's Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. They are at least 18-85 years old.
  2. They have recurrent VT (at least three episodes in the preceding six months) requiring therapy from an ICD, that is refractory to conventional treatments - both maximally tolerated doses of anti- arrhythmic drugs and/or conventional catheter ablation.
  3. They are too frail or do not wish to undergo conventional catheter ablation.
  4. They have not had previous radiotherapy to the anticipated treatment field.

Exclusion Criteria:

  1. They have polymorphic VT or ventricular fibrillation (VF).
  2. They have inotrope-dependent heart failure or a left ventricular assist device (LVAD) in situ.
  3. They are unlikely to live more than 12 months irrespective of the VT.
  4. There is a potentially reversible cause for the VT e.g. critical coronary artery disease or a metabolic problem such as an overactive thyroid gland.
  5. They are unable to provide informed consent.
  6. They have had previous radiotherapy to the anticipated treatment field.
  7. The patient weighs in excess of 170kg (maximum weight capacity of the tables in the imaging department).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment arm

Treatment with stereotactic ablative radiotherapy

Stereotactic ablative radiotherapy will be delivered to a volume of ventricular myocardium responsible for the clinical ventricular tachycardia.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in quality of life and cardiac complications as assessed by clinical history, SF-36 questionnaire, electrocardiogram and echocardiography.
Periodo de tiempo: 3 months

The number of serious adverse events at three months after treatment. This will be determined as follows:

  1. Clinical history from and examination of the patients assessing for new chest pains, breathlessness or coughing.
  2. SF-36 quality of life questionnaire.
  3. Echocardiography to assess for pericardial effusion that could indicate radiation-induced pericarditis.
  4. Electrocardiogram to assess for pericarditis or myocarditis caused by radiation.
3 months
Efficacy endpoint - Cumulative VT burden 6 months before and 6 months after radiotherapy.
Periodo de tiempo: 6 months

There will be a six week blanking period after radiotherapy to allow for ablation effect. The burden of VT will be assessed by interrogating the patient's ICD and assessing the number of episodes of non-sustained and sustained VT as well as the number of ICD therapies delivered.

6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
VT burden
Periodo de tiempo: 6 months

Cumulative VT burden in the second 6 months following radiotherapy. This will be assessed by ICD interrogation as described above.

6 months
Survival
Periodo de tiempo: 12 months

Overall survival at 3, 6 and 12 months following radiotherapy.

12 months
Cardiac function changes from radiotherapy
Periodo de tiempo: 12 months

Absolute change in numerical left ventricular ejection fraction assessed with echocardiography, at 3, 6 and 12 months.

12 months
Radiotherapy impact on ICD function
Periodo de tiempo: 12 months

Deterioration in implantable cardioverter-defibrillator function attributable to radiotherapy at 3, 6 and 12 months. This will be determined by interrogating the ICD and measuring the change in ICD defibrillator lead impedance.

12 months
Quality of life assessment using SF-36 questionnaire
Periodo de tiempo: 12 months

The SF-36 questionnaire will be used at 3, 6 and 12 months to assess this.

12 months
Heart failure status using New York Heart Association (NYHA) breathlessness class.
Periodo de tiempo: 12 months

Patients will be assessed at 3, 6 and 12 months by taking a history for breathlessness, scaled I to IV according to their NYHA class.

12 months
Cardiac conduction system status measured by ECG QRS duration.
Periodo de tiempo: 12 months

An electrocardiogram will be performed at 3, 6 and 12 months to look for any changes in the QRS complex duration.

12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de enero de 2023

Finalización primaria (Actual)

2 de mayo de 2025

Finalización del estudio (Actual)

2 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de febrero de 2022

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2023

Publicado por primera vez (Actual)

25 de enero de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 262246

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .