Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)
A legfontosabb adatok
- Ki végzi
- Rennes University Hospital
- Hol
- Franciaország12 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 150 fő, tervezett
- Kezdés
- 2023. okt. 23.
- Várható befejezés
- 2029. okt. 23.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Endo-epicardial ablation
- endocardial ablation only
- A regiszteradat frissítve
- 2025. június 27.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with heart disease caused by poor blood flow (ischaemic heart disease) who are having their first ablation for ventricular tachycardia, a fast heart rhythm. It compares ablation from inside the heart only with ablation from both inside and outside the heart.
- Életkor
- Over 18 years.
- Nem
- All sexes can join.
- A betegség stádiuma
- Ventricular tachycardia caused by ischaemic heart disease, with a first radiofrequency ablation planned.
- Korábbi kezelés
- People must already have an ICD (implanted defibrillator) with remote monitoring. This must be their first ablation for ventricular tachycardia.
A részvétel fő kizáró okai
- Past heart surgery that may block access to the outer heart surface, such as bypass or valve replacement
- Blood clot inside the left heart chamber seen on imaging before the procedure
- Blood thinners that cannot be stopped for a short time, or double antiplatelet therapy that cannot be reduced to one drug
- Past pericarditis, past chest radiotherapy, or past heparin-induced thrombocytopenia type 2
- Pregnant or breastfeeding women, or people who cannot have general anaesthesia
A regiszter feltételei, szó szerint
Mind a 16 feltétel megnézéseKevesebb
Ki vehet részt
- Patients over 18 years of age
- 1st radiofrequency ablation of VT complicating ischaemic heart disease
- Patients with an ICD and remote monitoring
- Having, for women of childbearing age, effective contraception until discharge from hospital
- Have given their free and informed consent in writing
- are affiliated to or have health insurance
Ki nem vehet részt
- Anticoagulant therapy that cannot be temporarily discontinued
- Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy
- Previous thoracic radiotherapy
- History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)
- History of pericarditis
- History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure)
- Presence of a left intraventricular thrombus found during pre-procedure imaging
- Contraindication to general anaesthesia
- Pregnant or breastfeeding woman
- Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV.
A teljes eredeti leírásKevesebb
First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial.
For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences.
The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.
A vizsgálat 2 csoportja
- Endo-epicardial ablationA vizsgált kezelés
- endocardial ablation onlyMár használt kezelés, összehasonlításként
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2025. június 27.