A multicenter prospective randomized study to evaluate the delivery timing safety and efficacy of AntiTachycardia Pacing
- Conditions
- Arrhythmias, CardiacD001145
- Registration Number
- JPRN-jRCT1022230003
- Lead Sponsor
- Ando Kenji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 398
Patient has an indication for ICD according to the JCS / 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 physicians instruction
- Patient is able to understand the nature of the study and to provide written informed consent
- Patient planned for implantation with or already implanted with CRT-D device
- A patient who is confirmed to have received ICD therapy
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To confirm the non-inferiority of Treatment Group to the Control Group in time to first shock from the day of the prescribed setting by Kaplan-Meier approach
- Secondary Outcome Measures
Name Time Method To verify whether it is effective or not by comparing the Treatment Group with ATP therapy and Control group about following items.<br>1. Success rate of the ATP<br>2. Duration until the end of the episode<br>3. Cardiac mortality