Ventricular TachycardiaCREVETNCT05973578
Cardiac RadiothErapy for VEntricular Tachycardia
A study testing Stereotactic radiotherapy in people with Ventricular Tachycardia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 23 May 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding
- Lack of evidence of a myocardial scar triggering the VT
- Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
- Advanced symptomatic heart failure defined as NYHA Class IV heart failure
- Previous radiotherapy with cardiac involvement
- Life expectancy < 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians
- Any condition that is deemed a contraindication in the judgment of the investigators
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Patrick Berkovic, MD, PhD
Patrick Berkovic, MD, PhD
About this study
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.
Read more
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.
- Conditions
- Ventricular Tachycardia
- Being tested
- 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 radiotherapyRadiation
Single-session high dose stereotactic radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiotherapy | Other | 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 Receives: Radiation: Stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of SBRT
Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient
Measured: From date of inclusion up to 1 year
Safety of SBRT
Measurement of acute and late toxicity assessed using the CTCAE v5.0
Measured: From radiotherapy up to 1 year
Secondary outcomes (2)
Efficacy of SBRT
Changes in the use of antiarrhythmic medication, reduction in VT burden
Measured: From inclusion up to 1 year
Health related quality-of-life
Measurement of the quality of life using the SF-36 questionnaire
Measured: From inclusion up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start23 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
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
- NCT05973578
- Sponsor's protocol ID
- s66934
- Acronym
- CREVET
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac RadiothErapy for VEntricular Tachycardia
- ClinicalTrials.gov ID
- NCT05973578
- Acronym / sponsor ID
- CREVET / s66934
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 3 Aug 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiotherapy | Other | Radiation: Stereotactic radiotherapyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Lack of evidence of a myocardial scar triggering the VT
- Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
- Advanced symptomatic heart failure defined as NYHA Class IV heart failure
- Previous radiotherapy with cardiac involvement
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 radiotherapySingle-session high dose stereotactic radiotherapy | Radiation | Stereotactic body radiotherapy |
Primary outcome
Feasibility of SBRT
Time frame: From date of inclusion up to 1 year
Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient
Safety of SBRT
Time frame: From radiotherapy up to 1 year
Measurement of acute and late toxicity assessed using the CTCAE v5.0
2 secondary outcomes
Efficacy of SBRT
Time frame: From inclusion up to 1 year
Health related quality-of-life
Time frame: From inclusion up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiotherapy in people with Ventricular Tachycardia, 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Berkovic, MD, PhD (+32-16-34-51-15, Patrick.berkovic@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of SBRT (time frame: From date of inclusion up to 1 year). The study lists 2 primary outcomes in all. 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 3 Aug 2023.