Tachycardia, VentricularNCT04334811
Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques
A study testing Stereotactic ablative radiotherapy in people with Tachycardia, Ventricular, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety of stereotactic ablative radiotherapy (SAbR), also known as stereotactic body radiation therapy (SBRT), for treatment of ventricular tachycardia (VT) requiring implantable cardioverter defibrillator (ICD) treatments in patients with VT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- Stereotactic ablative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2023to 1 Mar 2025
- 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
- Age ≥ 18 years
- Have an ICD implanted > 6 months and all VT episodes in the past 6 months are available in device memory.
- Within the past 3 months, the patient has at least one episode of symptomatic monomorphic VT that requires ICD treatment (anti-tachycardia pacing and/or ICD shock) or was sustained/incessant but falls under ICD treatment zone. These VT episodes must occur after at least one standard invasive VT ablation or occur in a patient that is clinically deemed not eligible to the standard VT ablation procedure.
- Two independent cardiac electrophysiologists reviewed the case and agreed that the patient would benefit from suppression of these VT episodes but there is no optimal invasive VT ablation or antiarrhythmic drug options.
Who cannot join
- Has contraindication to receive SAbR or VT clinically deemed not suitable for SAbR.
- Is pregnant
- Has severe co-morbid medical condition or terminal illness and is unlikely to survive more than 6 months regardless of VT status based on clinical judgement by treating or enrolling physicians.
- On potent immunosuppressive therapy (e.g., post organ transplant)
- Has severe collagen vascular disorder with organ involvement
- Not willing or not able to consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
The purpose of this study is to evaluate the clinical efficacy and safety of stereotactic ablative radiotherapy (SAbR), also known as stereotactic body radiation therapy (SBRT), for treatment of ventricular tachycardia (VT) requiring implantable cardioverter defibrillator (ICD) treatments in patients with VT refractory to standard invasive ablation techniques. We hypothesized that SAbR is effective in suppressing sustained VT and reducing ICD treatments in this group of patients and is associated with acceptably low risk of serious complications.
- Conditions
- Tachycardia, Ventricular
- Being tested
- Stereotactic ablative radiotherapy
- Keywords
- heart
- 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 ablative radiotherapyRadiation
Also called SAbR
Stereotactic ablative radiotherapy (SAbR) delivers of a potent, ablative or nearly ablative dose of radiation in oligofractions (ie, five or fewer fractions) primarily to create a compact dose delivered accurately to the intended target with steep gradients in all directions (geometric avoidance) and avoid damaging normal tissues.
| Study group | Role | What they receive |
|---|---|---|
| Arm | Other | No arm Receives: Radiation: Stereotactic ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy outcome of ICD (implantable cardioverter-defibrillator) Treatment
Number of episodes of ICD (implantable cardioverter-defibrillator) treatment (including both ATP and shock) per month; comparing 6 months before and after SAbR (excluding the first 2-week blanking period post SAbR).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study startFeb 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Why it stopped: The study was stopped due to participation in a multi-center randomized controlled trial with competing enrollment criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Daniels, University of Texas Southwestern Medical Center
- Investigators
- James Daniel, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334811
- Sponsor's protocol ID
- STU-2019-1023
- Status last verified
- Aug 2022
- First submitted
- 20 Feb 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques
- ClinicalTrials.gov ID
- NCT04334811
- Acronym / sponsor ID
- STU-2019-1023
- Conditions
- Tachycardia, Ventricular
- Keywords
- heart
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to participation in a multi-center randomized controlled trial with competing enrollment criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Apr 2020 (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.
The purpose of this study is to evaluate the clinical efficacy and safety of stereotactic ablative radiotherapy (SAbR), also known as stereotactic body radiation therapy (SBRT), for treatment of ventricular tachycardia (VT) requiring implantable cardioverter defibrillator (ICD) treatments in patients with VT refractory to standard invasive ablation techniques. We hypothesized that SAbR is effective in suppressing sustained VT and reducing ICD treatments in this group of patients and is associated with acceptably low risk of serious complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm | Other | Radiation: Stereotactic ablative radiotherapyNo arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Have an ICD implanted > 6 months and all VT episodes in the past 6 months are available in device memory.
- Within the past 3 months, the patient has at least one episode of symptomatic monomorphic VT that requires ICD treatment (anti-tachycardia pacing and/or ICD shock) or was sustained/incessant but falls under ICD treatment zone. These VT episodes must occur after at least one standard invasive VT ablation or occur in a patient that is clinically deemed not eligible to the standard VT ablation procedure.
- Two independent cardiac electrophysiologists reviewed the case and agreed that the patient would benefit from suppression of these VT episodes but there is no optimal invasive VT ablation or antiarrhythmic drug options.
Key exclusion criteria (6 listed)
- Has contraindication to receive SAbR or VT clinically deemed not suitable for SAbR.
- Is pregnant
- Has severe co-morbid medical condition or terminal illness and is unlikely to survive more than 6 months regardless of VT status based on clinical judgement by treating or enrolling physicians.
- On potent immunosuppressive therapy (e.g., post organ transplant)
- Has severe collagen vascular disorder with organ 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 ablative radiotherapyAlso: SAbRStereotactic ablative radiotherapy (SAbR) delivers of a potent, ablative or nearly ablative dose of radiation in oligofractions (ie, five or fewer fractions) primarily to create a compact dose delivered accurately to the intended target with steep gradients in all directions (geometric avoidance) and avoid damaging normal tissues. | Radiation | Arm |
Primary outcome
Primary efficacy outcome of ICD (implantable cardioverter-defibrillator) Treatment
Time frame: 6 months
Number of episodes of ICD (implantable cardioverter-defibrillator) treatment (including both ATP and shock) per month; comparing 6 months before and after SAbR (excluding the first 2-week blanking period post SAbR).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
Related trials for Tachycardia, Ventricular
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Assessment of Combined CCM and ICD Device in HFrEF
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Genetic Markers of Cardiovascular Disease in Epilepsy
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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.
James Daniel, MD principal investigator
University of Texas Southwestern Medical Center
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 ablative radiotherapy in people with Tachycardia, Ventricular, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Aug 2022. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy outcome of ICD (implantable cardioverter-defibrillator) Treatment (time frame: 6 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 17 Aug 2022.