Cardiac RadiothErapy for VEntricular Tachycardia II (CREVET II)

Cardiac RadiothErapy for VEntricular Tachycardia II - a Prospective Observational Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia (VT)
• Intervention / Treatment: Procedure: stereotactic radiotherapy ablation

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Bert Vandenberk, MD PhD; Phone Number: +3216338686; Email: bert.vandenberk@uzleuven.be
• Study Contact Backup: Name: Patrick Berkovic, MD PhD; Email: patrick.berkovic@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Bert Vandenberk, MD PhD; Phone Number: +3216338686; Email: bert.vandenberk@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state over a 48-month follow-up period.	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	Survival will be tracked during the 48-month follow-up period. In case of mortality, the cause of death will be registered.	48 months
Radiotherapy toxicity	The tolerable acute toxicity rate is defined as a 30-days follow-up without treatment-related grade ≥ 3 adverse events. Late toxicity is defined as toxicity occurring after at least 30 days after the radiation treatment. Toxicity will be assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).	48 months
Left ventricular function	Left ventricular function on transthoracic echocardiogram (TTE) by measuring left ventricular ejection fraction.	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	Change of pre-existing or new valve stenosis and insufficiency expressed as grade 0 / I / II / III / IV on transthoracic echocardiogram (TTE).	Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
Change of coronary artery disease	Presence and extent of coronary artery disease on CT coronary angiogram at 2 and 4 years follow-up using the calcium score and CAD-RADs stage.	Baseline, 2 years and 4 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ventricular tachycardia; Stereotactic radiotherapy; STAR
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: S69812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No