RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

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

Condition
Ventricular Tachycardia
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Age \< 18 years
  • * Pregnancy
  • * Prior chest radiation therapy

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

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

Study Record Dates

2030-12