VisszavonvaFázis nélkül
Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques
A legfontosabb adatok
- Ki végzi
- University of Texas Southwestern Medical Center
- Hol
- Dallas (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Visszavonva
- Kezdés
- 2023. febr.
- Befejezés
- 2025. márc. 1.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Stereotactic ablative radiotherapy
- A regiszteradat frissítve
- 2022. augusztus 17.
- Miért állt le
- The study was stopped due to participation in a multi-center randomized controlled trial with competing enrollment criteria.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- Age ≥ 18 years
- Have an ICD implanted > 6 months and all VT episodes in the past 6 months are available in device memory
- Within the past 3 months, the patient has at least one episode of symptomatic monomorphic VT that requires ICD treatment (anti-tachycardia pacing and/or ICD shock) or was sustained/incessant but falls under ICD treatment zone. These VT episodes must occur after at least one standard invasive VT ablation or occur in a patient that is clinically deemed not eligible to the standard VT ablation procedure
- Two independent cardiac electrophysiologists reviewed the case and agreed that the patient would benefit from suppression of these VT episodes but there is no optimal invasive VT ablation or antiarrhythmic drug options
Ki nem vehet részt
- On potent immunosuppressive therapy (e.g., post organ transplant)
- Has severe co-morbid medical condition or terminal illness and is unlikely to survive more than 6 months regardless of VT status based on clinical judgement by treating or enrolling physicians
- Has severe collagen vascular disorder with organ involvement
- Has contraindication to receive SAbR or VT clinically deemed not suitable for SAbR
- Is pregnant
- Not willing or not able to consent to participate in the study
Helyszínek itt: Egyesült Államok
- University of Texas Southwestern Medical Center - DallasDallas, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The purpose of this study is to evaluate the clinical efficacy and safety of stereotactic ablative radiotherapy (SAbR), also known as stereotactic body radiation therapy (SBRT), for treatment of ventricular tachycardia (VT) requiring implantable cardioverter defibrillator (ICD) treatments in patients with VT refractory to standard invasive ablation techniques. We hypothesized that SAbR is effective in suppressing sustained VT and reducing ICD treatments in this group of patients and is associated with acceptably low risk of serious complications.
A vizsgálat csoportja
- ArmEgyéb csoport
No arm
Kezelés: Stereotactic ablative radiotherapy
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2022. augusztus 17.