Cardiac ArrhythmiaPhase 1/2NCT05084391
Phase I/II Randomized Study of Stereotactic Ablative Radiotherapy (SABR) Versus Standard of Care for Refractory Structural Cardiac Arrhythmias (SABR-HEART)
A Phase 1/2 study testing stereotactic ablative radiotherapy (SABR) and Standard of Treatment in people with Cardiac Arrhythmia and Cardiac, run by M.D. Anderson Cancer Center.
Trial summary
Phase I: For the Phase I portion, there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. Efficacy as defined below will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia, Cardiac, Ventricular Tachyarrhythmias
- What is being tested?
- stereotactic ablative radiotherapy (SABR) and Standard of Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2019to 8 Feb 2024
- Phase
- Phase 1/2
- 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
- ECOG 0-2
- Age 18 years or older
- Diagnosis of recurrent sustained monomorphic VT (MMVT) in the setting of structural heart disease.
- ICD placement and at least two (2) episodes of recurrencerecurrent sustained MMVT that are terminated by anti-tachycardia pacing (ATP) or ICD shocks confirmed by device interrogation in the preceding 3 months, since the last VT ablation procedure in subjected who have failed catheter ablation.
- Failed at least 1 anti-arrhythmic medication (not including beta-blockers) as evidenced by persistent VT (including amiodarone and/or sotalol)
- At least 1 attempted catheter ablation procedure with voltage and/or activation 3D mapping. For patients with ischemic cardiomyopathy this would include failure of at least one endocardial ablation performed at an experienced center. For patients with non-ischemic cardiomyopathy, both endocardial and epicardial ablation should have been attempted unless epicardial ablation/mapping is not feasible (e.g. patient tolerance, deemed futile by EP, prior cardiac surgery).
- Patients are eligible regardless of past or present oncologic history (however, please refer to exclusion criterion #1 below, regarding life-expectancy of at least 12 months in the absence of VT)
Who cannot join
- Unlikely to live at least 12 months in the absence of VT, as assessed by physicians
- Heart failure dependent on ionotropes
- Left ventricular assist device
- Polymorphic VT
- Ventricular fibrillation
- 5 or more VT morphologies during stimulation testing suggestive of more than one arrhythmogenic substrate
Show all 21Show fewer
- Prior radiation treatment to the chest for any reason
- Last invasive catheter ablation attempt <2 weeks
- Lack of ICD data in preceding 3 months
- Unable/unwilling to provide informed consent
- Idiopathic VT
- Women who are pregnant
- Heart transplant
- Active ischemia or other reversible causes of VT
- Active non-cardiovascular illness or systemic infection
- Cardiogenic shock
- Presence of incessant VT that is hemodynamically unstable
- Acute heart failure exacerbation
- Revascularization in the past 30 days
- Left ventricular ejection fraction <15%
- Scar tissue exceeding 80cc in volume planning treatment volume (PTV) ≥300cc.
About this study
Phase I: For the Phase I portion, there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. Efficacy as defined below will also be assessed. Following this Phase I lead-in, results will be presented to the FDA for review. Only upon favorable analysis by the FDA committee, and with written explicit permission, will the Phase II randomized portion ensue. This is to act as a safety and efficacy safeguard and has is addressed more thoroughly in the Statistical Analysis Plan of this protocol.
Phase II: A 1:1 randomized Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care; Figure 3). Standard of care is defined as nationally recognized appropriate next treatment strategies for medical and catheter-ablation refractory structural cardiac VT that is assessed and judged appropriate for the patient by his/her treating cardiologist. This includes repeat catheter ablation (intravascular and/or epicardial catheter ablation), placement of left-ventricular assist device (LVAD), heart transplant, or further medical management (e.g. antiarrhythmic drug modulation/continuation). Randomization will be performed through the Clinical Trial Conduct (CTC) website.
Read the detailed description
Primary Objectives Phase I:
-Assess acute toxicity and efficacy with SABR in treating refractory structural cardiac ventricular tachyarrhythmias (VT). Ensure safety and treatment efficacy.
Primary Objectives Phase II:
- Investigate overall toxicity with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
- Investigate VT episode reduction with SABR compared to standard of care to evaluate effectiveness and potential superiority of SABR to current day options.
Primary Objectives Phase I:
- Assess acute toxicity and efficacy with SABR in treating refractory structural cardiac ventricular tachyarrhythmias (VT). Ensure safety and treatment efficacy.
Primary Objectives Phase II:
- Investigate overall toxicity with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
- Investigate VT episode reduction with SABR compared to standard of care to evaluate effectiveness and potential superiority of SABR to current day options.
Secondary Objectives
The following endpoints will be analyzed retrospectively based on prospectively collected (event-free survival endpoints) and at the specified time points (e.g. QOL questionnaire). Participation in QOL assessment and bio specimen collection for secondary endpoints is completely voluntary and not mandated by the trial.
- 6-month and 1-year overall survival (OS) of SABR compared to standard of care.
- Quality of life (QOL) with SABR compared to standard of care (baseline and at 6 months after randomization).
- Hospitalization-free survival with SABR compared to standard of care (evaluated at 1-year).
- Cost-effectiveness analysis with SABR compared to standard of care (evaluated at 1-year).
- Freedom-from Antiarrhythmic medications with SABR compared to standard of care (evaluated at 1-year).
- Freedom-from Electrical Storm with SABR compared to standard of care (evaluated at 1-year).
- Treatment-free Survival with SABR compared to standard of care (evaluated at 1-year).
- Event-free Survival with SABR compared to standard of care (evaluated at 1-year).
- Long term (>1year) toxicity with SABR compared to standard of care (evaluated at 1-year).
- Ejection fraction improvement with SABR compared to standard of care (evaluated at 1-year).
- Transplant/LVAD-free survival with SABR compared to standard of care (evaluated at 1-year).
- Number, type, and treatment success and cycle length of ICD-treated VTs with SABR compared to standard of care (evaluated at 1-year).
- Parameters obtained from cardiac imaging, and/or serum markers will be associated with frequency of survival, response to treatment, and toxicity at regular time intervals using cardiac ECHO, MRI, CT imaging, ICD interrogation, and/or serum/blood work studies for prognostic/predictive biomarker and radiomic identification.
- Conditions
- Cardiac Arrhythmia, Cardiac, Ventricular Tachyarrhythmias
- Being tested
- stereotactic ablative radiotherapy (SABR), Standard of Treatment
- Medical subject headings
- Arrhythmias, Cardiac, 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)Device
is safe for treating heart arrhythmias (irregular heartbeat
Standard of TreatmentOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Phase I: | Experimental | Phase I there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. Receives: Device: stereotactic ablative radiotherapy (SABR); Other: Standard of Treatment |
| Phase II | Experimental | Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care) Receives: Device: stereotactic ablative radiotherapy (SABR); Other: Standard of Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall toxicity as assessed using CTCAE v4.0 will be used with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start12 Sep 2019
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Why it stopped: 0 participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Joe Chang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084391
- Sponsor's protocol ID
- 2019-0538
- Other IDs
- NCI-2021-10672
- Status last verified
- Feb 2024
- First submitted
- 3 Sep 2021
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized Study of Stereotactic Ablative Radiotherapy (SABR) Versus Standard of Care for Refractory Structural Cardiac Arrhythmias (SABR-HEART)
- ClinicalTrials.gov ID
- NCT05084391
- Acronym / sponsor ID
- 2019-0538
- Conditions
- Cardiac Arrhythmia, Cardiac, Ventricular Tachyarrhythmias
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 participant accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 19 Oct 2021 (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.
Phase I: For the Phase I portion, there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. Efficacy as defined below will also be assessed. Following this Phase I lead-in, results will be presented to the FDA for review. Only upon favorable analysis by the FDA committee, and with written explicit permission, will the Phase II randomized portion ensue. This is to act as a safety and efficacy safeguard and has is addressed more thoroughly in the Statistical Analysis Plan of this protocol.
Phase II: A 1:1 randomized Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care; Figure 3). Standard of care is defined as nationally recognized appropriate next treatment strategies for medical and catheter-ablation refractory structural cardiac VT that is assessed and judged appropriate for the patient by his/her treating cardiologist. This includes repeat catheter ablation (intravascular and/or epicardial catheter ablation), placement of left-ventricular assist device (LVAD), heart transplant, or further medical management (e.g. antiarrhythmic drug modulation/continuation). Randomization will be performed through the Clinical Trial Conduct (CTC) website.
Detailed description
Primary Objectives Phase I:
-Assess acute toxicity and efficacy with SABR in treating refractory structural cardiac ventricular tachyarrhythmias (VT). Ensure safety and treatment efficacy.
Primary Objectives Phase II:
- Investigate overall toxicity with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
- Investigate VT episode reduction with SABR compared to standard of care to evaluate effectiveness and potential superiority of SABR to current day options.
Primary Objectives Phase I:
- Assess acute toxicity and efficacy with SABR in treating refractory structural cardiac ventricular tachyarrhythmias (VT). Ensure safety and treatment efficacy.
Primary Objectives Phase II:
- Investigate overall toxicity with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
- Investigate VT episode reduction with SABR compared to standard of care to evaluate effectiveness and potential superiority of SABR to current day options.
Secondary Objectives
The following endpoints will be analyzed retrospectively based on prospectively collected (event-free survival endpoints) and at the specified time points (e.g. QOL questionnaire). Participation in QOL assessment and bio specimen collection for secondary endpoints is completely voluntary and not mandated by the trial.
- 6-month and 1-year overall survival (OS) of SABR compared to standard of care.
- Quality of life (QOL) with SABR compared to standard of care (baseline and at 6 months after randomization).
- Hospitalization-free survival with SABR compared to standard of care (evaluated at 1-year).
- Cost-effectiveness analysis with SABR compared to standard of care (evaluated at 1-year).
- Freedom-from Antiarrhythmic medications with SABR compared to standard of care (evaluated at 1-year).
- Freedom-from Electrical Storm with SABR compared to standard of care (evaluated at 1-year).
- Treatment-free Survival with SABR compared to standard of care (evaluated at 1-year).
- Event-free Survival with SABR compared to standard of care (evaluated at 1-year).
- Long term (>1year) toxicity with SABR compared to standard of care (evaluated at 1-year).
- Ejection fraction improvement with SABR compared to standard of care (evaluated at 1-year).
- Transplant/LVAD-free survival with SABR compared to standard of care (evaluated at 1-year).
- Number, type, and treatment success and cycle length of ICD-treated VTs with SABR compared to standard of care (evaluated at 1-year).
- Parameters obtained from cardiac imaging, and/or serum markers will be associated with frequency of survival, response to treatment, and toxicity at regular time intervals using cardiac ECHO, MRI, CT imaging, ICD interrogation, and/or serum/blood work studies for prognostic/predictive biomarker and radiomic identification.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: | Experimental | Device: stereotactic ablative radiotherapy (SABR), Other: Standard of TreatmentPhase I there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. |
| Phase II | Experimental | Device: stereotactic ablative radiotherapy (SABR), Other: Standard of TreatmentPhase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG 0-2
- Age 18 years or older
- Diagnosis of recurrent sustained monomorphic VT (MMVT) in the setting of structural heart disease.
- ICD placement and at least two (2) episodes of recurrencerecurrent sustained MMVT that are terminated by anti-tachycardia pacing (ATP) or ICD shocks confirmed by device interrogation in the preceding 3 months, since the last VT ablation procedure in subjected who have failed catheter ablation.
- Failed at least 1 anti-arrhythmic medication (not including beta-blockers) as evidenced by persistent VT (including amiodarone and/or sotalol)
Key exclusion criteria (21 listed)
- Unlikely to live at least 12 months in the absence of VT, as assessed by physicians
- Heart failure dependent on ionotropes
- Left ventricular assist device
- Polymorphic VT
- Ventricular fibrillation
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)is safe for treating heart arrhythmias (irregular heartbeat | Device | Phase I:, Phase II |
| Standard of TreatmentStandard of care | Other | Phase I:, Phase II |
Primary outcome
The overall toxicity as assessed using CTCAE v4.0 will be used with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
Time frame: through study completion, an average of 1 year
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 13 Feb 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Joe Chang, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing stereotactic ablative radiotherapy (SABR) and Standard of Treatment in people with Cardiac Arrhythmia and Cardiac, run by M.D. Anderson Cancer Center.
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 21 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The overall toxicity as assessed using CTCAE v4.0 will be used with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT). (time frame: through study completion, an average of 1 year). 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 13 Feb 2024.