Refractory Ventricular TachycardiaNCT03349892
Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia
A study testing Stereotactic Ablative Radiotherapy (SABR) in people with Refractory Ventricular Tachycardia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Ventricular Tachycardia
- What is being tested?
- Stereotactic Ablative Radiotherapy (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 6 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy
- Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for cardiac sympathetic denervation therapy
- Documented ventricular arrhythmias refractory to or not a suitable candidate for cardiac transplantation
- Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for additional medical management
- ICD in place with documented episodes recurrent VT despite best clinical management previous refusal of ICD with recurrent sustained ventricular arrhythmias
- If ischemic cardiomyopathy, myocardial infarction occurred more than one month prior to enrollment
Show all 12Show fewer
- No history of prior radiotherapy to the chest
- Prescribed dose must be deliverable using SABR technique
- Age ≥ 18 years
- Karnofsky Performance Status (KPS) > 70
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment.
- Ability to understand and willingness to sign a written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Department of Radiation Oncology
Los Angeles, California, 90095-6951
About this study
Official title: Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study
Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as minimal dose of maximal effect. This design also allows for continual accrual of patients when delayed adverse events may be observed.
- Conditions
- Refractory Ventricular Tachycardia
- Being tested
- Stereotactic Ablative Radiotherapy (SABR)
- 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 Radiotherapy (SABR)Radiation
Also called external beam radiation
A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablation Treatment Arm | Experimental | This is a single-arm, non-blinded study. Receives: Radiation: Stereotactic Ablative Radiotherapy (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICD (Implantable Cardioverter Defibrillator) Shock Free Survival
ICD (implantable cardioverter defibrillator) shock free survival at six months
Measured: 6 months
Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)
Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.
Measured: 5 years
Secondary outcomes (2)
Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital
Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years
Measured: 5 years
Incidence of ICD Shocks
Incidence of ICD shocks 12 months post-SABR procedure
Measured: 12 months post-SABR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Apr 2017
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert K. Chin, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349892
- Sponsor's protocol ID
- Cardiac SABR
- Status last verified
- Oct 2021
- First submitted
- 17 Nov 2017
- Last updated
- 15 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study
- ClinicalTrials.gov ID
- NCT03349892
- Acronym / sponsor ID
- Cardiac SABR
- Conditions
- Refractory Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Posted 15 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as minimal dose of maximal effect. This design also allows for continual accrual of patients when delayed adverse events may be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Ablation Treatment Arm | Experimental | Radiation: Stereotactic Ablative Radiotherapy (SABR)This is a single-arm, non-blinded study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy
- Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for cardiac sympathetic denervation therapy
- Documented ventricular arrhythmias refractory to or not a suitable candidate for cardiac transplantation
- Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for additional medical management
- ICD in place with documented episodes recurrent VT despite best clinical management previous refusal of ICD with recurrent sustained ventricular arrhythmias
Key exclusion criteria (0 listed)
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 Radiotherapy (SABR)Also: external beam radiationA single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning. | Radiation | Stereotactic Ablation Treatment Arm |
Primary outcome
ICD (Implantable Cardioverter Defibrillator) Shock Free Survival
Time frame: 6 months
ICD (implantable cardioverter defibrillator) shock free survival at six months
Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)
Time frame: 5 years
Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.
2 secondary outcomes
Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital
Time frame: 5 years
Incidence of ICD Shocks
Time frame: 12 months post-SABR procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Refractory Ventricular Tachycardia
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Tachycardia, Ventricular
Not yet recruiting
Cardiac Radioablation for VT
Ventricular Tachycardia, Myocardial Infarction
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Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (SABR) in people with Refractory Ventricular Tachycardia, run by University of California, Los Angeles 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 12 inclusion and 0 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: finished, as of the sponsor's last update on 15 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
ICD (Implantable Cardioverter Defibrillator) Shock Free Survival (time frame: 6 months). 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 15 Nov 2021.