Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

Not Applicable

Recruiting

• Conditions: Ventricular Tachycardia

• Registration Number: NCT06743789
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular tachycardia (VT). These patients have not exhibited positive responses to conventional medications or procedures. This study aims to explore whether an alternative approach could yield more beneficial outcomes.

Detailed Description

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that arises from areas of diseased tissue in the heart. Treatment of VT can involve anti-arrhythmic drugs and catheter-based ablations. Unfortunately, despite multiple antiarrhythmic drugs, as well as the catheter-based ablation procedures, VT continues to persist in your case. At this point in time, The investigators believe that stereotactic body radiotherapy (SBRT) remains the only possible option to potentially treat VT. The investigators hypothesize that by administering SBRT at different dose levels and fractionation may achieve a better therapeutic ratio, defined as comparable efficacy with less risk of toxicity due to lower dose exposure to the normal tissue, including the heart vasculature, in patients when compared to VT patients who receive a dose of 25Gy in a single fraction which is the current treatment option.

This is a randomized dose de-escalation trial where the patients will be randomized in in one of the two experimental arms, receiving 1 single fraction OR 3 daily consecutive fractions of RT, and will be treated into a prespecified dose level group, based on the study development. The study includes three de-escalated consecutive dose level groups for each of two randomized treatment arms and there will be 3 patients per group and each group will receive a particular radiation treatment either as single treatments or three treatments.

The purpose of this treatment is to safely reduce episodes of VT.

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study Start: 2024-12-18
• Study First Posted: 2024-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2028-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥ 18 years

• Structural heart disease:

  1. Ischemic cardiomyopathy
  2. Non-ischemic cardiomyopathy
  3. Hypertrophic cardiomyopathy

• Refractory VT severity:

  1. VT leading to ICD shock with minimum 3 episodes in any 3-month period without reversible cause;
  2. Failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 AADs) AND failed ablation (CA)
  3. OR ablation (CA) contraindicated

• Ability to understand study protocol and to write informed consent

• Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements

• Expected to remain available for at least 36 months after enrollment

Exclusion Criteria

• Age < 18 years
• Pregnancy
• Prior chest radiation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes	6 weeks post treatment
Number of treatment-related serious adverse events (SAEs)	6 weeks post treatment	Safety: SAEs rate ≤ 30% defined using Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) that could be treatment-related (possibly, probably, or definitely related to treatment) at 6 weeks after treatment is considered clinically acceptable.; The SAEs are defined as any grade 3 toxicity requiring hospitalization or any grade 4 to 5 toxicity.

Secondary Outcome Measures

Name	Time	Method
Number of ventricular tachycardia (VT) episodes	12 months
Number of subacute treatment side-effects	6 months post	Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
Number of late Adverse events	2 year post	Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
Overall survival	2 year post	Overall survival, defined as time calculated from treatment to death for any cause;
Recurrence free survival	24 months post	Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours
Number of incidents of implantable cardiac device (ICD) shock	3 months post treatment
Number of Anti-Arrhythmic Drugs (AADs) administration	3 months post treatment	Any reduction in Anti-Arrhythmic Drugs (AADs) administration

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States