Status:
RECRUITING
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
Lead Sponsor:
Biotronik SE & Co. KG
Collaborating Sponsors:
Biotronik Japan, Inc.
Conditions:
Implantable Cardioverter Defibrillator(ICD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
Detailed Description
The enrolled patients are randomized to Treatment Group with setting to provide Antitachycardiac Pacing (ATP) multiple times at an early timing or Control Group with Long Detection setting for the con...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patient planned for implantation with or already implanted with Cardiac Resynchronization Therapy Defibrillator (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
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT05426785
Start Date
May 15 2023
End Date
May 31 2028
Last Update
February 3 2025
Active Locations (1)
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1
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, ８０２８５５５