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

NCT05426785 | Active Not Recruiting

• 1 other identifier: TA119
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

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

Conditions

Implantable Cardioverter Defibrillator(ICD)

Keywords

ICD; shock; Antitachycardiac Pacing(ATP); Ventricular Tachycardia(VT); Ventricular Fibrillation(VF); Ventricular arrhythmias(VA)

Outcome Measures

Primary Outcomes (1)

• 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.

  From a minimum of 18 months to a maximum of 42 months

Secondary Outcomes (3)

• Success rate of the ATP

  From a minimum of 18 months to a maximum of 42 months

• Duration until the end of the episode

  From a minimum of 18 months to a maximum of 42 months

• Cardiac mortality

  From a minimum of 18 months to a maximum of 42 months

Study Arms (2)

Treatment Group(Early Multiple ATP Group)

ACTIVE COMPARATOR

Set to perform multiple ATP early

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)

Device: 1:1 ratio for Treatment Group and Control Group

Interventions

1:1 ratio for Treatment Group and Control Group DEVICE

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.

Control Group; Treatment Group(Early Multiple ATP Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead
• Biotronik Japan, Inc.: collaborator

Study Sites (1)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, ８０２８５５５, Japan

Location

Related Publications (5)

• 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.

  PMID: 33232811 RESULT

• Arenal 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.

  PMID: 27485577 RESULT

• Sterns 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.

  PMID: 26988379 RESULT

• Joung 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.

  PMID: 31369873 RESULT

• Yokoshiki 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.

  PMID: 32782648 RESULT

MeSH Terms

Conditions

Shock; Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dr. Kenji Ando

  Kokura Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 ratio

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 22, 2022
• Study Start: May 15, 2023
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after 6 months of Lst Patient Out (LPO)
• Access Criteria: Following Sponsor'ｓStandard Operating Procedures ()

Locations

JP (1)