Cardiac RadiothErapy for VEntricular Tachycardia II

NCT06744530 | Recruiting

• 1 other identifier: S69812
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Steoreotactic therapy radioablation has become a standard of care option for patients with therapy-refractory ventricular tachycardia, yet long-term outcome is lacking. The objective of this study is to evaluate the long-term outcomes, both efficacy and safety, after STAR in patients with therapy-refractory ventricular tachycardia.

Conditions

Ventricular Tachycardia (VT)

Keywords

ventricular tachycardia; STAR; Stereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

• Change in VT burden

  Change in VT burden, measured as the frequency of appropriate ICD interventions or documented VT episodes over a 48-month follow-up period. The ICD interrogations are part of standard of care and the majority of patients are included in remote monitoring which automatically sends new VT episodes to the telemonitoring team. The efficacy of STAR will be assessed by analysing both the total VT burden, but also time to first VT event (with and without a 6 week blanking period).

  48 months

Secondary Outcomes (6)

• Quality of Life

  Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months

• All-cause mortality

  48 months

• Radiotherapy toxicity

  48 months

• Left ventricular function

  Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months

• Evolution of valve disease

  Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months

Interventions

stereotactic radiotherapy ablation PROCEDURE

Single dose of 25 Gy up to 32.5 Gy on the myocardium in patients with therapy-refractory ventricular tachycardia

Also known as: STAR, stereotactic body radiotherapy

Eligibility Criteria

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

Study Population

All patients with therapy-refractory ventricular tachycardia who are scheduled for stereotactic radiotherapy ablation (STAR) are eligible for participation.

You may qualify if:

• Eligible for STAR for therapy-refractory VT based on a multidisciplinary discussion
• Ability to give a written informed consent and willingness to return for follow-up

You may not qualify if:

• Contra-indications for STAR, including pregnancy or breastfeeding, previous radiotherapy with cardiac involvement, life-expectancy \< 6 months in the absence of VT
• Any condition that is deemed a contraindication in the judgment of the investigators

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Bert Vandenberk, MD PhD

CONTACT

+3216338686; bert.vandenberk@uzleuven.be

Patrick Berkovic, MD PhD

CONTACT

patrick.berkovic@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2034
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

BE (1)