Phase I/II Randomized Study of Stereotactic Ablative Radiotherapy (SABR) Versus Standard of Care for Refractory Structural Cardiac Arrhythmias (SABR-HEART)
Megadott ok: 0 participant accrual
A legfontosabb adatok
- Fázis
- 1/2. fázis
A vizsgálat adatai
- Ki végzi
- M.D. Anderson Cancer Center
- Azonosító
- NCT05084391
- A regiszteradat frissítve
- 2024. február 13.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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).
Kizáró feltételek: Prior radiation treatment to the chest for any reason; Heart failure dependent on ionotropes; Heart transplant; Active non-cardiovascular illness or systemic infection; Acute heart failure exacerbation; Left ventricular ejection fraction <15%; Unlikely to live at least 12 months in the absence of VT, as assessed by physicians; Left ventricular assist device; Polymorphic VT; Ventricular fibrillation; 5 or more VT morphologies during stimulation testing suggestive of more than one arrhythmogenic substrate; 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; Active ischemia or other reversible causes of VT; Cardiogenic shock; Presence of incessant VT that is hemodynamically unstable; Revascularization in the past 30 days; Scar tissue exceeding 80cc in volume planning treatment volume (PTV) ≥300cc.