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

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.

Conditions

• Ventricular Tachycardia

Interventions

RADIATION

Radiation Therapy

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

Radiation Therapy

Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)

RADIATION

Radiation Therapy

Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)

RADIATION

Radiation Therapy

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

Radiation Therapy

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

Radiation Therapy

Group 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)

Sponsors & Collaborators

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Silvia Formenti, M.D. · Weill Medical College of Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-18

Primary Completion

2028-12-31

Completion

2030-12-31

FDA Device

Yes

Countries

• United States

Study Locations