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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2028-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Implantable Cardioverter Defibrillator(ICD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 ratio

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group(Early Multiple ATP Group)

Set to perform multiple ATP early

Group Type ACTIVE_COMPARATOR

1:1 ratio for Treatment Group and Control Group

Intervention Type DEVICE

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.

Control Group

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)

Group Type ACTIVE_COMPARATOR

1:1 ratio for Treatment Group and Control Group

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No