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

Biotronik

Status: Enrolling

Conditions: Implantable Cardioverter Defibrillator(ICD)

Treatments: Device: 1:1 ratio for Treatment Group and Control Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT05426785

TA119

Details and patient eligibility

About

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

Full 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 conventional ATP, at latest 10 days after the implantation of the Implantable Cardioverter Defibrillator(ICD) system in the domestic centers to confirm the safety and efficacy of the setting for the early timing multiple ATP treatment in Japanese patients.

The follow-up is not pre-defined and the data (including the home monitoring data) is collected according to the site's standard outpatient schedule, but the data will be collected at the hospital visit for the initial appropriate or inappropriate shock therapy.

Enrollment: 398 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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398 participants in 2 patient groups

Treatment Group(Early Multiple ATP Group)

Active Comparator group

Description:

Set to perform multiple ATP early

Treatment:

Device: 1:1 ratio for Treatment Group and Control Group

Control Group

Active Comparator group

Description:

Set the extended detection time for the conventional ATP (Refer to the settings of "Delayed Therapy-arm C" in Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy (MADIT-RIT) study)

Treatment:

Device: 1:1 ratio for Treatment Group and Control Group