Implantable Cardioverter Defibrillator(ICD)BIO|ATPNCT05426785
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
A study of Implantable Cardioverter Defibrillator(ICD), run by Biotronik SE & Co. KG at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardioverter Defibrillator(ICD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteJapan
- Study dates
- 15 May 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- 1:1 ratio for Treatment Group and Control Group
- Keywords
- ICD, shock, Antitachycardiac Pacing(ATP), Ventricular Tachycardia(VT), Ventricular Fibrillation(VF), Ventricular arrhythmias(VA)
- Medical subject headings
- Shock, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1:1 ratio for Treatment Group and Control GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group(Early Multiple ATP Group) | Active comparator | Set to perform multiple ATP early Receives: Device: 1:1 ratio for Treatment Group and Control Group |
| Control Group | Active comparator | 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) Receives: Device: 1:1 ratio for Treatment Group and Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first shock by Kaplan-Meier approach
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.
Measured: From a minimum of 18 months to a maximum of 42 months
Secondary outcomes (3)
Success rate of the ATP
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.
Measured: From a minimum of 18 months to a maximum of 42 months
Duration until the end of the episode
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.
Measured: From a minimum of 18 months to a maximum of 42 months
Cardiac mortality
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.
Measured: From a minimum of 18 months to a maximum of 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start15 May 2023
- Primary completion10 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Implantable Cardioverter Defibrillator(ICD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik Japan, Inc.
- Responsible party
- Sponsor
- Investigators
- Dr. Kenji Ando, Principal investigator, Kokura Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426785
- Sponsor's protocol ID
- TA119
- Acronym
- BIO|ATP
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Schuger C, Daubert JP, Zareba W, Rosero S, Yong P, McNitt S, Kutyifa V. Reassessing the role of antitachycardia pacing in fast ventricular arrhythmias in primary prevention implantable cardioverter-defibrillator recipients: Results from MADIT-RIT. Heart Rhythm. 2021 Mar;18(3):399-403. doi: 10.1016/j.hrthm.2020.11.019. Epub 2020 Nov 21.
PubMed 33232811Arenal A, Proclemer A, Kloppe A, Lunati M, Martinez Ferrer JB, Hersi A, Gulaj M, Wijffels MC, Santi E, Manotta L, Mangoni L, Gasparini M. Different impact of long-detection interval and anti-tachycardia pacing in reducing unnecessary shocks: data from the ADVANCE III trial. Europace. 2016 Nov;18(11):1719-1725. doi: 10.1093/europace/euw032. Epub 2016 Aug 2.
PubMed 27485577Sterns LD, Meine M, Kurita T, Meijer A, Auricchio A, Ando K, Leng CT, Okumura K, Sapp JL, Brown ML, Lexcen DR, Gerritse B, Schloss EJ. Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST. Heart Rhythm. 2016 Jul;13(7):1489-96. doi: 10.1016/j.hrthm.2016.03.022. Epub 2016 Mar 14.
PubMed 26988379Joung B, Lexcen DR, Ching CK, Silver MT, Piccini JP, Sterns LD, Rabinovich R, Pickett RA, Liu S, Brown ML, Cheng A. Additional antitachycardia pacing programming strategies further reduce unnecessary implantable cardioverter-defibrillator shocks. Heart Rhythm. 2020 Jan;17(1):98-105. doi: 10.1016/j.hrthm.2019.07.027. Epub 2019 Jul 29.
PubMed 31369873Yokoshiki H, Shimizu A, Mitsuhashi T, Ishibashi K, Kabutoya T, Yoshiga Y, Kohno R, Abe H, Nogami A; Members of the Implantable Cardioverter-Defibrillator (ICD) Committee of the Japanese Heart Rhythm Society. Trends in the use of implantable cardioverter-defibrillator and cardiac resynchronization therapy device in advancing age: Analysis of the Japan cardiac device treatment registry database. J Arrhythm. 2020 Jun 8;36(4):737-745. doi: 10.1002/joa3.12377. eCollection 2020 Aug.
PubMed 32782648
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Study to Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing
- ClinicalTrials.gov ID
- NCT05426785
- Acronym / sponsor ID
- BIO|ATP / TA119
- Keywords
- ICD, shock, Antitachycardiac Pacing(ATP), Ventricular Tachycardia(VT), Ventricular Fibrillation(VF), Ventricular arrhythmias(VA)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Biotronik Japan, Inc.
- Study start
- 15 May 2023 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Treatment Group(Early Multiple ATP Group) | Active comparator | Device: 1:1 ratio for Treatment Group and Control GroupSet to perform multiple ATP early |
| Control Group | Active comparator | Device: 1:1 ratio for Treatment Group and Control GroupSet 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1:1 ratio for Treatment Group and Control GroupRandomization 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. | Device | Control Group, Treatment Group(Early Multiple ATP Group) |
Primary outcome
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.
3 secondary outcomes
Success rate of the ATP
Time frame: 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
Cardiac mortality
Time frame: From a minimum of 18 months to a maximum of 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 33232811Schuger C, Daubert JP, Zareba W, Rosero S, Yong P, McNitt S, Kutyifa V. Reassessing the role of antitachycardia pacing in fast ventricular arrhythmias in primary prevention implantable cardioverter-defibrillator recipients: Results from MADIT-RIT. Heart Rhythm. 2021 Mar;18(3):399-403. doi: 10.1016/j.hrthm.2020.11.019. Epub 2020 Nov 21.
- Results publication: PubMed 27485577Arenal A, Proclemer A, Kloppe A, Lunati M, Martinez Ferrer JB, Hersi A, Gulaj M, Wijffels MC, Santi E, Manotta L, Mangoni L, Gasparini M. Different impact of long-detection interval and anti-tachycardia pacing in reducing unnecessary shocks: data from the ADVANCE III trial. Europace. 2016 Nov;18(11):1719-1725. doi: 10.1093/europace/euw032. Epub 2016 Aug 2.
- Results publication: PubMed 26988379Sterns LD, Meine M, Kurita T, Meijer A, Auricchio A, Ando K, Leng CT, Okumura K, Sapp JL, Brown ML, Lexcen DR, Gerritse B, Schloss EJ. Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST. Heart Rhythm. 2016 Jul;13(7):1489-96. doi: 10.1016/j.hrthm.2016.03.022. Epub 2016 Mar 14.
- Results publication: PubMed 31369873Joung B, Lexcen DR, Ching CK, Silver MT, Piccini JP, Sterns LD, Rabinovich R, Pickett RA, Liu S, Brown ML, Cheng A. Additional antitachycardia pacing programming strategies further reduce unnecessary implantable cardioverter-defibrillator shocks. Heart Rhythm. 2020 Jan;17(1):98-105. doi: 10.1016/j.hrthm.2019.07.027. Epub 2019 Jul 29.
- Results publication: PubMed 32782648Yokoshiki H, Shimizu A, Mitsuhashi T, Ishibashi K, Kabutoya T, Yoshiga Y, Kohno R, Abe H, Nogami A; Members of the Implantable Cardioverter-Defibrillator (ICD) Committee of the Japanese Heart Rhythm Society. Trends in the use of implantable cardioverter-defibrillator and cardiac resynchronization therapy device in advancing age: Analysis of the Japan cardiac device treatment registry database. J Arrhythm. 2020 Jun 8;36(4):737-745. doi: 10.1002/joa3.12377. eCollection 2020 Aug.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Kenji Ando principal investigator
Kokura Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Implantable Cardioverter Defibrillator(ICD), run by Biotronik SE & Co. KG at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first shock by Kaplan-Meier approach (time frame: From a minimum of 18 months to a maximum of 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426785, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.