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

October 12, 2023 updated by: Biotronik SE & Co. KG

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Fukuoka
      • Kitakyushu-city, Fukuoka, Japan, ８０２８５５５

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment Group(Early Multiple ATP Group)
Set to perform multiple ATP early
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.
Active Comparator: 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first shock by Kaplan-Meier approach
Time Frame: From a minimum of 18 months to a maximum of 42 months
During the study duration(42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), to confirm that Treatment Group is the non-inferiority to the Control Group in terms of the time from randomized prescriptive settings to first shock with ICD device treatment, by Kaplan-Meier approach. The time frame of event evaluation is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
From a minimum of 18 months to a maximum of 42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of the ATP
Time Frame: From a minimum of 18 months to a maximum of 42 months
During the study duration (42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), calculate the percentage of successful ATP treatment for all collected ATP treatment episodes. The definition of ATP success is that confirming by one beat of sinus rhythm or Atrial Pacing (in case of Atrial fibrillation, the electrical complex on an Electrocardiogram (ECG) related to the depolarization of the ventricles (QRS) or Ventricular Pacing) under the tachycardia detection rate. The time frame of event collections is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
From a minimum of 18 months to a maximum of 42 months
Duration until the end of the episode
Time Frame: From a minimum of 18 months to a maximum of 42 months
For all episodes collected during the study duration (42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), the time from the onset to the termination of the episode recorded in the ICD device is measured as the episode duration. The time frame of event collections is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
From a minimum of 18 months to a maximum of 42 months
Cardiac mortality
Time Frame: From a minimum of 18 months to a maximum of 42 months
During the study duration (42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), confirm the occurrence of cardiac mortality in all enrolled patients.The time frame of evaluation of cardiac mortality is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
From a minimum of 18 months to a maximum of 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Collaborators

Biotronik Japan, Inc.

Investigators

  • Principal Investigator: Dr. Kenji Ando, Kokura Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TA119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study is the domestic multicenter clinical study, and the Publication Steering Committee(PSC) consisting of researchers may perform the analysis in accordance with the decision by PSC after first publication.

IPD Sharing Time Frame

Data will be available after 6 months of Lst Patient Out (LPO)

IPD Sharing Access Criteria

Following Sponsor'ｓStandard Operating Procedures ()

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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