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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06743789
Status
Recruiting
Apply to this trial

Conditions

  • Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — RADIATION
    Group 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)
  • Radiation Therapy — RADIATION
    Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
  • Radiation Therapy — RADIATION
    Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
  • Radiation Therapy — RADIATION
    Group 1 (3 participants) - will receive a dose of 12 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)
  • Radiation Therapy — RADIATION
    Group 2 (3 participants) - will receive a dose of 10 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)
  • Radiation Therapy — RADIATION
    Group 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)

Study Details

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.

Key Dates

Start date
Dec 18, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 20 Gy Radiation Dose (Arm 1 Group 1)
    Arm 1: Group 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)
  • Experimental: 15 Gy Radiation Dose (Arm 1 Group 2)
    Arm 1: Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
  • Experimental: 10 Gy Radiation Dose (Arm 1 Group 3)
    Arm 1: Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
  • Experimental: 12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1)
    Arm 2: Group 1 (3 participants) - will receive a dose of 12 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)
  • Experimental: 10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2)
    Arm 2: Group 2 (3 participants) - will receive a dose of 10 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)
  • Experimental: 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3)
    Arm 2: Group 3 (3 participants) - will receive a dose of 8 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)

Primary Outcome Measure

Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes [ Time Frame: 6 months before treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Fabiana Gregucci, M.D
[email protected]
646-962-3110
Fereshteh Talebi, M.D
[email protected]
646-702-7830
Silvia Formenti, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY

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