Ventricular Tachycardia (VT)CREVET IINCT06744530
Cardiac RadiothErapy for VEntricular Tachycardia II
An observational study of Ventricular Tachycardia (VT), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT)
- What is being tested?
- stereotactic radiotherapy ablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2025to Dec 2034
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with therapy-refractory ventricular tachycardia who are scheduled for stereotactic radiotherapy ablation (STAR) are eligible for participation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Berkovic, MD PhD contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Bert Vandenberk, MD PhD, +3216338686, bert.vandenberk@uzleuven.be
About this study
Official title: 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.
- Conditions
- Ventricular Tachycardia (VT)
- Being tested
- stereotactic radiotherapy ablation
- Keywords
- ventricular tachycardia, STAR, Stereotactic radiotherapy
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiotherapy ablationProcedure or surgery
Also called STAR, stereotactic body radiotherapy
Single dose of 25 Gy up to 32.5 Gy on the myocardium in patients with therapy-refractory ventricular tachycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 48 months
Left ventricular function
Left ventricular function on transthoracic echocardiogram (TTE) by measuring left ventricular ejection fraction.
Measured: 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).
Measured: 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.
Measured: Baseline, 2 years and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025
- Primary completionDec 2033 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744530
- Sponsor's protocol ID
- S69812
- Acronym
- CREVET II
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac RadiothErapy for VEntricular Tachycardia II - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06744530
- Acronym / sponsor ID
- CREVET II / S69812
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- ventricular tachycardia, STAR, Stereotactic radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with therapy-refractory ventricular tachycardia who are scheduled for stereotactic radiotherapy ablation (STAR) are eligible for participation.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic radiotherapy ablationAlso: STAR, stereotactic body radiotherapySingle dose of 25 Gy up to 32.5 Gy on the myocardium in patients with therapy-refractory ventricular tachycardia | Procedure or surgery | – |
Primary outcome
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).
6 secondary outcomes
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
All-cause mortality
Time frame: 48 months
Radiotherapy toxicity
Time frame: 48 months
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
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 coronary artery disease
Time frame: Baseline, 2 years and 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Berkovic, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia (VT), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bert Vandenberk, MD PhD (+3216338686, bert.vandenberk@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VT burden (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.