To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
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A vizsgálat adatai
- Ki végzi
- Biotronik SE & Co. KG
- Azonosító
- NCT05426785
- A regiszteradat frissítve
- 2026. április 27.
- Eredeti leírás
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacyA teljes eredeti leírásKevesebb
A Multicenter Prospective Randomized Study to Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
Bevonási feltételek: Patient has an indication for ICD according to the The Japanese Circulation Society (JCS )/ Japanese Heart Rhythm Society (JHRS) 2021 Guideline Focused Update on Non-Pharmacotherapy of Cardiac Arrhythmias; Patient is either planned for de novo ICD implantation or is already implanted with an investigational ICD for 10 days or less; Patient can be treated with ATP therapy for both VT and VF zone; Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept; Patient is willing to visit the hospital in accordance with physician's instruction; Patient is able to understand the nature of the study and to provide written informed consent.
Kizáró feltételek: A patient who is confirmed to have received ICD therapy; Patient planned for implantation with or already implanted with Cardiac Resynchronization Therapy Defibrillator (CRT-D) device; A patient who is diagnosed as Idiopathic VF (e.g. Brugada syndrome, Long QT Syndrome, other IVF); Age < 18 years; A patient who has impaired mental status; Life expectancy less than 18 months; Participation in another interventional clinical investigation; Pregnant or breastfeeding.