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Stereotactic Ablative Radiotherapy for the Treatment of Refractory Ventricular Tachycardia

Study acronym: SABRE-VT
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Lead sponsor: Barts & The London NHS Trust to Barts & The London NHS Trust Show 7 more changesShow less
    • Trial completed
    • Final enrollment: 4 participants (planned 6)
    • Primary completion date changed from estimate of May 2, 2026 to May 2, 2025
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description revised
    • Site details revised
  2. Notable Primary completion date: May 2, 2025 to May 2, 2026v3
  3. Notable Primary completion date: May 2, 2024 to May 2, 2025
    • Start date changed from estimate of Jan 21, 2023 to Jan 12, 2023
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05696522
Lead Sponsor Barts & The London NHS Trust
Conditions
(from sponsor)
Radiotherapy; Complications, Ventricular Tachycardia, Structural Heart Abnormality, Heart Failure
Related terms Heart Failure, Tachycardia, Ventricular
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov