To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Time to first shock by Kaplan-Meier approach [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.
Secondary Outcome Measures
- Success rate of the ATP [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.
- Duration until the end of the episode [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.
- Cardiac mortality [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Patient is either planned for de novo ICD implantation or is already implanted with an investigational ICD for 10 days or less.
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Patient can be treated with ATP therapy for both VT and VF zone
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Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept
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Patient is willing to visit the hospital in accordance with physician's instruction
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Patient is able to understand the nature of the study and to provide written informed consent
Exclusion Criteria:
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Patient planned for implantation with or already implanted with Cardiac Resynchronization Therapy Defibrillator (CRT-D) device
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A patient who is confirmed to have received ICD therapy
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A patient who is diagnosed as Idiopathic VF (e.g. Brugada syndrome, Long QT Syndrome, other IVF)
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Age < 18 years
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A patient who has impaired mental status
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Life expectancy less than 18 months
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Participation in another interventional clinical investigation
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Pregnant or breastfeeding
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Biotronik SE & Co. KG
- Biotronik Japan, Inc.
Investigators
- Principal Investigator: Dr. Kenji Ando, Kokura Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TA119