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 range18 Years
SexALL
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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…
What they're measuring
1
Reduction in ICD treatments for VT (≥ 50 percent)