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Clinical Trials in Japan / NCT05426785
Active, not recruiting Not applicable

To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)

NCT05426785 · tracked via the Priya Life Science Japan tracker
Sponsor
Biotronik SE & Co. KG
Phase
Not applicable
Started
2023-05-15
Last updated
2026-04-27

Condition(s) studied

Implantable Cardioverter Defibrillator(ICD)

Investigational drug(s) / intervention(s)

1:1 ratio for Treatment Group and Control Group

1:1 ratio for Treatment Group and Control Group: Randomization also will be performed at latest 10 days after ICD implantation, and the specified device programming settings for the allocated group will be set after successful implantation of the investigational devices.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Time to first shock by Kaplan-Meier approach — From a minimum of 18 months to a maximum of 42 months
    During the study duration(42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), to confirm that Treatment Group is the non-inferiority to the Control Group in terms of the time from randomized prescriptive settings to first shock with ICD device treatment, by Kaplan-Meier approach. The time frame of event evaluation is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.

Trial sites (1)

FacilityCityRegionStatus
Kokura Memorial Hospital Kitakyushu Fukuoka

More Biotronik SE & Co. KG trials in Japan

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05426785 on ClinicalTrials.gov ↗ ← All trials in Japan