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

NCT05426785 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2026-04-27

No results posted yet for this study

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

Conditions

  • Implantable Cardioverter Defibrillator(ICD)

Interventions

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.

Sponsors & Collaborators

  • Biotronik Japan, Inc.

    collaborator INDUSTRY

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Dr. Kenji Ando · Kokura Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2027-05-10
Completion
2027-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426785 on ClinicalTrials.gov