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NCT Number: NCT06744530

Cardiac RadiothErapy for VEntricular Tachycardia II

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stereotactic radiotherapy ablation

Procedure

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

Other names: STAR, stereotactic body radiotherapy

Primary outcomes

  1. Change in VT burden

    Time frame: 48 months

    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).

Secondary outcomes

  1. Quality of Life

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

    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.

  2. All-cause mortality

    Time frame: 48 months

    Survival will be tracked during the 48-month follow-up period. In case of mortality, the cause of death will be registered.

  3. Radiotherapy toxicity

    Time frame: 48 months

    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).

  4. Left ventricular function

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

    Left ventricular function on transthoracic echocardiogram (TTE) by measuring left ventricular ejection fraction.

  5. Evolution of valve disease

    Time frame: 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 pre-existing or new valve stenosis and insufficiency expressed as grade 0 / I / II / III / IV on transthoracic echocardiogram (TTE).

  6. Change of coronary artery disease

    Time frame: Baseline, 2 years and 4 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bert Vandenberk, MD PhD

CONTACT

[email protected]

+3216338686

Patrick Berkovic, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: CREVET II

Important dates

Study start
2025
Primary completion
2033
Study completion
2034
First posted
Dec 20, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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