SBRT in Chagas Disease Ventricular Tachycardia

NCT04984265 | Active Not Recruiting Phase 1

• 1 other identifier: 4920/19/139
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study of 10 Chagas Disease patients with Ventricular Tachycardia that have failed prior catheter ablation or have this procedure contraindicated due to clinical status. Those patients will underwent to Stereotactic Body Radiation Therapy (SBRT) targeting the area of the heart of the VT circuits. Radioablation target will be defined based on prior ablation electroanatomical mapping, VT morphology, pre-acquired imaging (CT angiogram, Cardiac Magnetic Resonance), current imaging reconstructed and integrated to electroanatomical mapping and a EP study to define current VT morphologies. Gross targeted volume (GTV), internal targeted volume (ITV) and planning targeted volume (PTV) will be defined and calculated and a single 25Gy dose will be delivered to the PTV. Patients will be followed initially for one year and efficacy endpoint will be rate of VT recurrence, time to recurrence and VT burden. Safety endpoint will be the occurrence of any adverse effect related to SBRT.

Conditions

Ventricular Tachycardia; Chagas Disease; Cardiac Arrhythmia

Keywords

Cardiac Radioablation; Chagas Disease; Refractory Ventricular Tachycardia; Stereotactic Body Radiation Therapy; SBRT

Outcome Measures

Primary Outcomes (2)

• Safety of SBRT for the treatment of Ventricular Tachycardia

  Incidence of cardiac and extra-cardiac adverse effects related to SBRT

  12 months

• Efficacy of SBRT for the treatment of Ventricular Tachycardia

  Rate of VT recurrence after a blanking period of 6 weeks following SBRT

  12 months

Secondary Outcomes (4)

• Time to VT Recurrence

  12 months

• VT Burden

  12 months

• Mortality

  12 months

• Cardiac Mortality

  12 months

Study Arms (1)

Stereotactic Body rRadiotherapy (SBRT)

EXPERIMENTAL

SBRT targeting the area of the circuit of Ventricular Tachycardia

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

SBRT targeting the area of the circuit of Ventricular Tachycardia

Also known as: SBRT

Stereotactic Body rRadiotherapy (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Chagas heart disease including positive serology
• Recurrent sustained ventricular tachycardia requiring therapy due to symptoms, ICD shocks, or requiring hospitalization.
• Age\>18 years.
• Able to give written, informed consent. If the patient requires continuous sedation/anesthesia for arrhythmia control consent can be provided by the next of kin.
• Medically fit to undergo radiation planning and treatment sessions.
• Failed antiarrhythmic medications due to VT recurrence, drug intolerance, or contraindication.
• Failed prior catheter ablation due to arrhythmia recurrence or ineligible for endocardial or epicardial catheter ablation (LV thrombus, epicardial adhesion, megacolon, prior open chest surgery)

You may not qualify if:

• Cardiogenic shock not due to VT with no possibility of heart transplant or ventricular assist device.
• Inability for patient to be adequately immobilized for radiation planning and treatment.
• Repeat catheter ablation is felt to be a reasonable option.
• Previous radiation to the chest.
• Pregnancy or refusal to use contraception.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Chagas Disease; Arrhythmias, Cardiac

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mauricio I Scanavacca, MD, PhD

  University of São Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: July 14, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

BR (1)