Noninvasive Cardiac Radioablation for Ventricular Tachycardia Refractory to Medication and Cathet… (NCT04757688) | Clinical Trial Compass
WithdrawnNot Applicable
Noninvasive Cardiac Radioablation for Ventricular Tachycardia Refractory to Medication and Catheter Ablation
Stopped: Difficulty with accrual
United States0Started 2022-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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%.
* 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 wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.