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Search / Trial NCT06360939

Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

Launched by WESTERN SYDNEY LOCAL HEALTH DISTRICT · Apr 7, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Catheter Ablation Stereotactic Body Radiation Therapy Non Invasive Radioablation

ClinConnect Summary

This clinical trial is studying two different treatments for a heart condition called ventricular tachycardia (VT), which is a fast and sometimes dangerous heartbeat. The researchers want to find out if a type of radiation therapy called stereotactic body radiation therapy (SBRT) is as effective as the standard treatment, catheter ablation (CA), in reducing the number of VT episodes in patients with serious heart disease. They will look at how well each treatment works over six months and compare any side effects from both methods.

To be eligible for this trial, participants should be adults aged 65 to 74 with specific heart problems, such as certain types of heart muscle diseases or previous episodes of VT. They should also have a high risk of more VT episodes. Participants will receive either SBRT or CA and will be closely monitored throughout the study to see how they respond to their assigned treatment. It's important to note that this trial is not yet recruiting participants, and there are specific criteria that may exclude some patients, such as having a life expectancy of less than three months or being pregnant.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of
  • 1. segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI
  • 2. myocardial hypertrophy
  • 3. myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography)
  • 2. Recurrent monomorphic VT which can include
  • 1. at least one episode of VT treated by ICD and/or
  • 2. sustained VT (lasting \>30s) and/or
  • 3. inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS)
  • 3. PAINESD score of ≥9 points and/or at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and/or mortality after CA.
  • Exclusion Criteria:
  • 1. Age \< 18 years
  • 2. Life expectancy \< 3 months
  • 3. Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.
  • 4. Unwilling or unable to provide consent
  • 5. Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
  • 6. Contraindications to radiotherapy as deemed by referring physician and/or radiation oncologist
  • 7. Pregnancy or breast feeding

About Western Sydney Local Health District

Western Sydney Local Health District (WSLHD) is a leading healthcare organization dedicated to delivering high-quality medical services and advancing clinical research within the Western Sydney region. As a prominent sponsor of clinical trials, WSLHD focuses on fostering innovation and improving patient outcomes through rigorous scientific investigation. By collaborating with healthcare professionals, researchers, and community stakeholders, WSLHD aims to enhance the understanding of various health conditions and develop effective treatments, all while ensuring the highest standards of ethical practice and patient safety.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported