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To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
Sponsor: Biotronik SE & Co. KG
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
Official title: A Multicenter Prospective Randomized Study to Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
398
Start Date
2023-05-15
Completion Date
2028-05-31
Last Updated
2025-02-03
Healthy Volunteers
No
Interventions
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.
Locations (1)
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan