A multicenter prospective randomized study to evaluate the delivery timing safety and efficacy of AntiTachycardia Pacing

JRCT ID: jRCT1022230003

Registered date:15/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Arrhythmias, Cardiac
• Date of first enrollment: 17/06/2023
• Target sample size: 398
• Study type: Interventional

Intervention(s)

<Group allocation>
Baseline assessment starts after the patient provides written informed consent and completes at latest 10 days after ICD implantation. 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.
Treatment Group (Early Multiple ATP Group): Set to perform multiple ATP early
Control Group: Set the extended detection time for the conventional ATP
<Follow-Up>
The follow-up visits specified in this CIP are only when the initial appropriate or inappropriate shock therapy occurs, the subject will visit to the hospital within 14 days (in the case where the initial shock therapy is inappropriate, the subject will also visit to the hospital within 14 days of the first appropriate shock therapy), and other than that, the data is collected according to the site's standard outpatient schedule.

Outcome(s)

• Primary Outcome: 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

To verify whether it is effective or not by comparing the Treatment Group with ATP therapy and Control group about following items.
1. Success rate of the ATP
2. Duration until the end of the episode
3. Cardiac mortality

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Ando Kenji
• Secondary Sponsor: Noda Takashi,BIOTRONIK SE & Co. KG
• Secondary ID(s): NCT05426785