RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-18
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06743789

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Structural heart disease:
  3. 1. Ischemic cardiomyopathy
  4. 2. Non-ischemic cardiomyopathy
  5. 3. Hypertrophic cardiomyopathy
  6. * Refractory VT severity:
  7. 1. VT leading to ICD shock with minimum 3 episodes in any 3-month period without reversible cause;
  8. 2. Failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 AADs) AND failed ablation (CA)
  9. 3. OR ablation (CA) contraindicated
  10. * Ability to understand study protocol and to write informed consent
  11. * Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
  12. * Expected to remain available for at least 36 months after enrollment
  1. * Age \< 18 years
  2. * Pregnancy
  3. * Prior chest radiation therapy

Contacts and Locations

Study Contact

Fabiana Gregucci, M.D.
CONTACT
646 962 2199
fgr4002@med.cornell.edu
Fereshteh Talebi, M.D.
CONTACT
646 702 7830
fet4007@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-18
Study Completion Date2030-12

Study Record Updates

Study Start Date2024-12-18
Study Completion Date2030-12

Terms related to this study

Additional Relevant MeSH Terms

  • Ventricular Tachycardia