NCT05426785

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

A Multicenter Prospective Randomized Study to Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 398 (estimated)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

• Implantable Cardioverter Defibrillator(ICD)

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-05-15
• Primary completion: 2027-12-31
• Completion: 2028-05-31
• First posted: 2022-06-22
• Last updated: 2025-02-03

Locations

1 site across 1 country: Japan