A Phase 1/2 interventional study of stereotactic body radiotherapy (SBRT) in Ventricular Tachycardia, Cardiomyopathy and Premature Ventricular Contractions, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Washington University School of Medicine · Phase 1/2, Interventional, and Treatment
Among 154 studies in Tachycardia, Ventricular with a site in United States — 34 open to participants now, 40 under way, 2 of them phase 3. Tachycardia, Ventricular · United States.
Among the 154 studies in Tachycardia, Ventricular with a site in United States, this one is the 78th largest by enrollment of the 107 interventional ones, is one of 5 that started in 2016, is the only one in phase 1/2, and was the 71st registered.
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's enrollment of 19 is below the median of 71 across 280 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →34 of the 154 studies in Tachycardia, Ventricular with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 85 Tachycardia, Ventricular studies recruiting now, 66 (78%) set no upper age limit and 1 (1%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →154 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 5 started in 2016.
Median enrollment 60 across the 107 interventional studies, 142 across the 47 observational. Of the 99 that completed or were terminated, 51 (52%) have results posted.
52 of 154 have an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 1 study filed under Tachycardia, Ventricular — fewer than ten, so there is no comparison to draw.
13 of the studies in Tachycardia, Ventricular with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06281977Phase 3Ottawa Heart Institute Research CorporationStudy Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm | 2027-05-08 |
| NCT06703489Medtronic Cardiac Ablation SolutionsSafety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) | 2026-11 |
| NCT06138873Rush University Medical CenterAblation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy | 2026-11-23 |
| NCT04520347University of California, Los AngelesIVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry | 2026-12 |
| NCT06747013Vivek ReddyTreatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA | 2027-02 |
Among the 154 studies in Tachycardia, Ventricular with a site in United States, from their registry updates:
Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of Ventricular Tachycardia
Patients with Ventricular Tachycardia (VT) who have failed standard therapy (medicines, invasive catheter ablation) have limited options, with one-year survival below 20%. Preclinical data demonstrate that single fraction stereotactic body radiotherapy (SBRT) to discrete portions of the heart is feasible and may result in a reduction or elimination of VT. The efficacy may be further improved when guided by cardiac electrophysiologic (EP) testing. In total, the mapping and ablation proposed for this EP-guided Noninvasive Cardiac Radioablation (ENCORE) is a rapid and totally non-invasive method. Overall safety and early efficacy of ENCORE have not been rigorously studied in a prospective trial to-date. The purpose of this phase I/II study is to demonstrate the short-term safety and preliminary efficacy of ENCORE for patients with life-threatening, treatment-refractory VT.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
DOCUMENTED VT:
Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead or intracardiac ICD interrogation
ANTIARRHYTHMIC MEDICATION: Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).
-AND-
MINIMUM VT BURDEN: Patient must have either:
-
Exclusion Criteria:
Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.
Radiation: stereotactic body radiotherapy (SBRT)
(Cardiac ablative radiotherapy)
Number of Serious Adverse Events
Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures.
Time frame: < or = 90 days
Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden
Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (\>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors.
Time frame: 12 months (6mo prior to and 6mo post SBRT)
Overall Survival
Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE.
Time frame: 12 months
Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment
Toxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria.
Time frame: 90 days to 12 months
Health Related Quality of Life (HRQOL)
The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state.
Time frame: 6 week, 6 month, 12 month
Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden
Evaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (\>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be \>50% reduction in PVC burden based on ambulatory heart monitors.
Time frame: 6 months
Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden
Evaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (\>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (\<1%) based on ambulatory heart monitors.
Time frame: 6 months
Number of Participants With Reduction in ICD Shocks and LVEF Improvement
Evaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden.
Time frame: 6 months
Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months
Evaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (\>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase.
Time frame: 12 months
Twenty-one patients were consented between July 11, 2016 and December 20, 2017. These patients were evaluated as either inpatient or outpatient. Once patients met initial enrollment criteria, screening procedures were conducted to determine if the patient was eligible for SBRT.
| Milestone | Patients Overall Who Received SBRT |
|---|---|
| Started | 19 |
| Primary safety endpoint (</=90 days) | 19 |
| Primary efficacy endpoint (6 months) | 18 |
| Completed | 18 |
| Not completed | 1 |
| Withdrew: Death | 1 |
Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures.
| Events | Number of Events |
|---|---|
| Grade 3 treatment-related SAE | 2 |
| Grade 4 treatment-related SAE | 0 |
| Grade 5 treatment-related SAE | 0 |
| Grade 5 SAE (not treatment-related) | 1 |
Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (\>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors.
| Participants | Patients With ICD-treated VT Indication | Patients With PVC-Related Cardiomyopathy Indication |
|---|---|---|
| Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden | 15 | 2 |
Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE.
| Participants | 6 Month Overall Survival | 12 Month Overall Survival |
|---|---|---|
| Overall Survival | 18 | 13 |
Toxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria.
| Number of Events | Number of Events |
|---|---|
| Grade 1 Possibly Related AE | 15 |
| Grade 1 Probably Related AE | 1 |
| Grade 2 Possibly Related AE | 9 |
| Grade 2 Probably Related AE | 1 |
| Grade 2 Definitely Related AE | 1 |
| Grade 3 Possibly Related AE | 20 |
| Grade 4 Possibly Related AE | 1 |
| Grade 5 Possibly Related AE | 1 |
The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state.
| Scores on a Scale | Baseline | 6 Week | 6 Month | 12 Month |
|---|---|---|---|---|
| Social Functioning | 64 (25 to 100) | 70 (13 to 100) | 87 (50 to 100) | 72 (38 to 100) |
| General Health | 44 (10 to 85) | 52 (15 to 95) | 49 (6 to 90) | 54 (15 to 85) |
| Health Change | 28 (0 to 75) | 61 (25 to 100) | 77 (0 to 100) | 65 (0 to 100) |
Evaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (\>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be \>50% reduction in PVC burden based on ambulatory heart monitors.
| Participants | Patients Overall Who Received SBRT |
|---|---|
| Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden | 17 |
Evaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (\>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (\<1%) based on ambulatory heart monitors.
| Participants | Patients Overall Who Received SBRT |
|---|---|
| Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden | 11 |
Evaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden.
| Participants | Patients Overall Who Received SBRT |
|---|---|
| Number of Participants With Reduction in ICD Shocks and LVEF Improvement | 13 |
Evaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (\>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase.
| Participants | Patients Overall Who Received SBRT |
|---|---|
| Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months | 16 |
Collected over Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Overall Who Received SBRT | 8/19 (42.1%) | 15/19 (78.9%) | 19/19 (100%) |
| Event | Patients Overall Who Received SBRT |
|---|---|
| Ventricular TachycardiaCardiac disorders | 9/19 |
| Heart FailureCardiac disorders | 6/19 |
| Cardiac ArrestCardiac disorders | 3/19 |
| HypotensionVascular disorders | 3/19 |
| Acute Kidney InjuryRenal and urinary disorders | 2/19 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/19 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/19 |
| Other - Chest Pain NOSCardiac disorders | 2/19 |
| Other - PneumoniaRespiratory, thoracic and mediastinal disorders | 2/19 |
| Pericardial EffusionCardiac disorders | 2/19 |
| Event | Patients Overall Who Received SBRT |
|---|---|
| FatigueGeneral disorders | 12/19 |
| DizzinessNervous system disorders | 9/19 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 8/19 |
| Heart FailureCardiac disorders | 8/19 |
| HypotensionVascular disorders | 8/19 |
| Other - Chest Pain NOSCardiac disorders | 8/19 |
| DyspepsiaGastrointestinal disorders | 6/19 |
| NauseaGastrointestinal disorders | 6/19 |
| Pericardial EffusionCardiac disorders | 5/19 |
| VomitingGastrointestinal disorders | 5/19 |
| Age, Continuous(years) | Patients Overall Who Received SBRT |
|---|---|
| Median | 66 (49 to 81) |
| Sex: Female, Male(Participants) | Patients Overall Who Received SBRT |
|---|---|
| Female | 2 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | Patients Overall Who Received SBRT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| BMI(kg/m^2) | Patients Overall Who Received SBRT |
|---|---|
| Median | 33.0 (24.3 to 48.6) |
| Age-Adjusted Charlson Comorbidity Index(Score) | Patients Overall Who Received SBRT |
|---|---|
| Median | 4 (2 to 13) |
| Type of Cardiomyopathy(Participants) | Patients Overall Who Received SBRT |
|---|---|
| Ischemic Cardiomyopathy | 11 |
| Nonischemic Cardiomyopathy | 8 |
| Type of Nonischemic Cardiomyopathy(Participants) | Patients Overall Who Received SBRT |
|---|---|
| Idiopathic | 5 |
| Myocarditis (Chronic) | 2 |
| Valvular | 1 |
| New York Heart Association (NYHA) Class(Participants) | Patients Overall Who Received SBRT |
|---|---|
| NYHA I | 1 |
| NYHA II | 4 |
| NYHA III | 10 |
| NYHA IV | 4 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Open sharing at the time of publication of results
Supporting information: Study protocol
Ran from Jul 2016 to primary completion in Jul 2018, 24 months.
Results were first posted in Sep 2019, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine →