Ventricular TachycardiaRAD 1901NCT04757688
Noninvasive Cardiac Radioablation for Ventricular Tachycardia Refractory to Medication and Catheter Ablation
A study testing Cardiac radioablation (CRA) in people with Ventricular Tachycardia, run by John Stahl at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of cardiac radioablation (CRA) as a means of noninvasive treatment of ventricular tachycardia (VT) refractory to both medication and catheter ablation. 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?
- Cardiac radioablation (CRA)
- 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
- Nov 2022to Jun 2028
- 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
- Patients must be ≥ 18 years old.
- Patients must have documented sustained monomorphic VT by 12-lead ECG or intracardiac ICD interrogation.
- Minimum VT burden: 4 or more documented VT episodes (including sustained VT, ICD anti-tachycardia pacing [ATP], or ICD shock) in the 5 months preceding enrollment on this trial. Patients must have at least two episodes of electrocardiographically documented symptomatic, recurrent, sustained monomorphic VT in the 3 months prior to enrollment
- *ATP and appropriate ICD shock are acceptable surrogates for VT-associated symptoms
- Patients must have an ICD.
- Patients must have ischemic or non-ischemic cardiomyopathy previously diagnosed with LVEF ≤ 35%.
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- Patients must have received at least one antiarrhythmic medication (i.e. amiodarone, sotalol, mexiletine) without control of symptoms or with poor toleration. AND Patients must have undergone at least one catheter-ablation procedure (or have a contraindication to catheter-ablation) or have VT arising from an inaccessible location.
- Contra-indications to endocardial catheter ablation procedure include dual aortic and mitral mechanical valves, active left ventricular thrombus, and anesthesia intolerance.
- Contra-indications to epicardial catheter ablation include prior cardiac surgery or anesthesia intolerance.
- Patients with ischemic cardiomyopathy should have failed at least one endocardial ablation performed at an academic center.
- Patients with non-ischemic cardiomyopathy should have failed both epicardial and endocardial ablations, unless epicardial mapping/ablation is not feasible.
- Ability to understand and willingness to sign an IRB approved informed consent document (legally authorized representatives are not permissible).
- An independent EP cardiologist must confirm that each study participant has met the study entrance criteria, has failed conventional therapies, and has frequent recurrent VT episodes that warrant further rhythm management.
Who cannot join
- Patients who have received any prior radiotherapy to the internal organs of the thorax or upper abdomen (with treatment field extending superior to L1 vertebral body) at any time in the past are excluded.
- Patients found to have multiple scars on electrocardiographic imaging where the source of reentrant focus is unclear despite positron emission tomography (PET)/magnetic resonance imaging (MRI) are excluded.
- Patients who have congestive heart failure on inotropes (NYHA class 4B) or left-ventricular assist device are excluded.
- Patients felt to be unlikely to live 12 months in the absence of VT are excluded.
- Patients with polymorphic VT or ventricular fibrillation, >3 distinct clinical VT morphologies on ICD interrogation, or >5 induced VT morphologies during noninvasive testing are excluded.
- Patients with multiple, spatially separate target substrates (targets with presumed inclusion of nonadjacent ventricular segments) deemed unsafe to treat with CRA by the treating physician will be excluded.
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- Patients with incessant VT that is hemodynamically unstable are excluded.
- Patients in VT storm are excluded.
- Patients must not be pregnant and must have a negative pregnancy test within 14 days of study entry if they are females of childbearing age.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham (UAB) Department of Radiation Oncology
Birmingham, Alabama, 35249
About this study
Official title: RAD 1901: Noninvasive Cardiac Radioablation for Ventricular Tachycardia Refractory to Medication and Catheter Ablation
The purpose of this study is to evaluate the safety and efficacy of cardiac radioablation (CRA) as a means of noninvasive treatment of ventricular tachycardia (VT) refractory to both medication and catheter ablation.
Read the detailed description
Ventricular tachycardia (VT) is a regular, rapid (faster than 100 beats per minute) abnormal heart rhythm resulting from aberrant electrical conduction in the ventricles of the heart. Coronary heart disease is responsible for the majority of VT cases. Defibrillation and antitachycardia pacing, effective means of terminating a life-threatening acute episode of VT, can be delivered via implantable cardioverter-defibrillator (ICD). ICDs are able to both monitor the heart rhythm continuously and deliver therapy in response to tachycardia that meets pre-programmed detection criteria. For patients with VT refractory to medical management requiring multiple ICD shocks, electrophysiologic mapping may be utilized to localize the arrhythmogenic focus, which can be subsequently ablated with cardiac catheter radiofrequency ablation. The goal of catheter ablation is to identify (through electroanatomical mapping) and then eliminate the channels of surviving myocardium within the substrate. Many patients experience continued episodes of VT refractory to both medication and multiple catheter ablation attempts. ICD shocks are associated with substantially increased risk of hospitalization, quality of life impairment, and death.
Stereotactic body radiotherapy (SBRT) is a technique used most commonly as a cancer treatment, whereby a precise, high dose of radiation is delivered to a target. For patients with VT refractory to medication and catheter ablation, noninvasive targeting of the arrhythmogenic substrate with SBRT (in this case termed cardiac radioablation, CRA) is an emerging technique demonstrating favorable efficacy.
Using a protocol similar to that utilized by the phase I/II ENCORE-VT trial (NCT02919618), this study aims to replicate previously reported favorable results in a multi-institutional setting. Accrued patients will receive CRA to 25 Gy in a single fraction.
- Conditions
- Ventricular Tachycardia
- Being tested
- Cardiac radioablation (CRA)
- Keywords
- Cardiac radioablation, Cardiac SBRT
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac radioablation (CRA)Radiation
CRA to 25 Gy in 1 fraction
| Study group | Role | What they receive |
|---|---|---|
| Cardiac radioablation (CRA) | Experimental | CRA delivered via linear accelerator (stereotactic body radiotherapy) to the suspected arrhythmogenic substrate to a dose of 25 Gy in 1 fraction. Receives: Radiation: Cardiac radioablation (CRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in ICD treatments for VT (≥ 50 percent)
Number of subjects with ≥ 50 percent reduction in number of ICD treatments for VT (shocks or anti-tachycardia pacing, ATP) comparing 5 month period before CRA to 6 months after CRA (excluding 1 month blanking period post CRA).
Measured: 6 months
Secondary outcomes (3)
Severe adverse event rate ≤ 20 percent
Demonstration of a ≤ 20 percent rate of severe adverse events within 90 days of CRA.
Measured: 3 months
Reduction in ICD treatments for VT (≥ 95 percent)
Number of subjects with ≥ 95 percent reduction in number of ICD treatments (shocks or ATP) for VT comparing 5 month period before CRA to 6 months after CRA (excluding 1 month blanking period post CRA).
Measured: 6 months
Elimination of ICD shocks
Number of subjects with elimination of ICD shocks.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study startNov 2022 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Why it stopped: Difficulty with accrual
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.
- 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
- John Stahl
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor-investigator, John Stahl, University of Alabama at Birmingham
- Investigators
- John Stahl, MD, Principal investigator, University of Alabama at Birmingham (UAB)Cliff Robinson, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757688
- Sponsor's protocol ID
- IRB-300006881
- Acronym
- RAD 1901
- Status last verified
- Nov 2022
- First submitted
- 12 Feb 2021
- Last updated
- 9 Nov 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD 1901: Noninvasive Cardiac Radioablation for Ventricular Tachycardia Refractory to Medication and Catheter Ablation
- ClinicalTrials.gov ID
- NCT04757688
- Acronym / sponsor ID
- RAD 1901 / IRB-300006881
- Conditions
- Ventricular Tachycardia
- Keywords
- Cardiac radioablation, Cardiac SBRT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- John StahlUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Nov 2022 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Feb 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.
The purpose of this study is to evaluate the safety and efficacy of cardiac radioablation (CRA) as a means of noninvasive treatment of ventricular tachycardia (VT) refractory to both medication and catheter ablation.
Detailed description
Ventricular tachycardia (VT) is a regular, rapid (faster than 100 beats per minute) abnormal heart rhythm resulting from aberrant electrical conduction in the ventricles of the heart. Coronary heart disease is responsible for the majority of VT cases. Defibrillation and antitachycardia pacing, effective means of terminating a life-threatening acute episode of VT, can be delivered via implantable cardioverter-defibrillator (ICD). ICDs are able to both monitor the heart rhythm continuously and deliver therapy in response to tachycardia that meets pre-programmed detection criteria. For patients with VT refractory to medical management requiring multiple ICD shocks, electrophysiologic mapping may be utilized to localize the arrhythmogenic focus, which can be subsequently ablated with cardiac catheter radiofrequency ablation. The goal of catheter ablation is to identify (through electroanatomical mapping) and then eliminate the channels of surviving myocardium within the substrate. Many patients experience continued episodes of VT refractory to both medication and multiple catheter ablation attempts. ICD shocks are associated with substantially increased risk of hospitalization, quality of life impairment, and death.
Stereotactic body radiotherapy (SBRT) is a technique used most commonly as a cancer treatment, whereby a precise, high dose of radiation is delivered to a target. For patients with VT refractory to medication and catheter ablation, noninvasive targeting of the arrhythmogenic substrate with SBRT (in this case termed cardiac radioablation, CRA) is an emerging technique demonstrating favorable efficacy.
Using a protocol similar to that utilized by the phase I/II ENCORE-VT trial (NCT02919618), this study aims to replicate previously reported favorable results in a multi-institutional setting. Accrued patients will receive CRA to 25 Gy in a single fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac radioablation (CRA) | Experimental | Radiation: Cardiac radioablation (CRA)CRA delivered via linear accelerator (stereotactic body radiotherapy) to the suspected arrhythmogenic substrate to a dose of 25 Gy in 1 fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must be ≥ 18 years old.
- Patients must have documented sustained monomorphic VT by 12-lead ECG or intracardiac ICD interrogation.
- Patients must have an ICD.
- Patients must have ischemic or non-ischemic cardiomyopathy previously diagnosed with LVEF ≤ 35%.
- Patients must have received at least one antiarrhythmic medication (i.e. amiodarone, sotalol, mexiletine) without control of symptoms or with poor toleration. AND Patients must have undergone at least one catheter-ablation procedure (or have a contraindication to catheter-ablation) or have VT arising from an inaccessible location.
Key exclusion criteria (9 listed)
- Patients who have received any prior radiotherapy to the internal organs of the thorax or upper abdomen (with treatment field extending superior to L1 vertebral body) at any time in the past are excluded.
- Patients found to have multiple scars on electrocardiographic imaging where the source of reentrant focus is unclear despite positron emission tomography (PET)/magnetic resonance imaging (MRI) are excluded.
- Patients who have congestive heart failure on inotropes (NYHA class 4B) or left-ventricular assist device are excluded.
- Patients felt to be unlikely to live 12 months in the absence of VT are excluded.
- Patients with polymorphic VT or ventricular fibrillation, >3 distinct clinical VT morphologies on ICD interrogation, or >5 induced VT morphologies during noninvasive testing are excluded.
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 |
|---|---|---|
| Cardiac radioablation (CRA)CRA to 25 Gy in 1 fraction | Radiation | Cardiac radioablation (CRA) |
Primary outcome
Reduction in ICD treatments for VT (≥ 50 percent)
Time frame: 6 months
Number of subjects with ≥ 50 percent reduction in number of ICD treatments for VT (shocks or anti-tachycardia pacing, ATP) comparing 5 month period before CRA to 6 months after CRA (excluding 1 month blanking period post CRA).
3 secondary outcomes
Severe adverse event rate ≤ 20 percent
Time frame: 3 months
Reduction in ICD treatments for VT (≥ 95 percent)
Time frame: 6 months
Elimination of ICD shocks
Time frame: 5 years
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 9 Nov 2022.
Related trials for Ventricular Tachycardia
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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
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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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.
John Stahl, MD principal investigator
University of Alabama at Birmingham (UAB)
Cliff Robinson, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac radioablation (CRA) in people with Ventricular Tachycardia, run by John Stahl 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 13 inclusion and 9 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 9 Nov 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?
Reduction in ICD treatments for VT (≥ 50 percent) (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 9 Nov 2022.