Cardiac RadiothErapy for VEntricular Tachycardia

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To explore in our center the feasibility and safety of a SBRT treatment method for VT. Study population: Patients with ventricular tachycardia that are refractory to dose-escalated antiarrhythmic drugs and where catheter ablation has either already been performed or is deemed to be unsuccessful or associated with high risks. Intervention: Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate defined by electrophysiological mapping. Main study endpoints: The primary aim is to explore the feasibility and safety of a SBRT treatment method for refractory VT. Secondary endpoints include an assessment of the efficacy of the treatment, quality of life, late toxicity and overall survival. Patients will have to fill in a quality-of-life questionnaire before and after the radiotherapy treatment. The risk associated with this trial is an increase in toxicity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient ≥ 18 years

• Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD)

• Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation)

• The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement

• Patient must have failed or become intolerant to at least one antiarrhythmic medication

• Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location

• Ability to give a written informed consent and willingness to return for follow-up

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Patrick Berkovic, MD, PhD
Patrick.berkovic@uzleuven.be
+32-16-34-51-15
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 5
Treatments
Other: Stereotactic body radiotherapy
Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov