Clinical trial NCT05426785: To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
Official title: A Multicenter Prospective Randomized Study to Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implantable Cardioverter Defibrillator(ICD)
Keywords: ICD
shock
Antitachycardiac Pacing(ATP)
Ventricular Tachycardia(VT)
Ventricular Fibrillation(VF)
Ventricular arrhythmias(VA)
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Biotronik Japan, Inc.
First posted: 2022-06-22
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 ratio
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first shock by Kaplan-Meier approach
timeFrame: From a minimum of 18 months to a maximum of 42 months
Secondary outcomes:
measure: Success rate of the ATP
timeFrame: From a minimum of 18 months to a maximum of 42 months
measure: Duration until the end of the episode
timeFrame: From a minimum of 18 months to a maximum of 42 months
measure: Cardiac mortality
timeFrame: From a minimum of 18 months to a maximum of 42 months
Other outcomes:
Locations:
city: Kitakyushu-city
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
Study officials:
affiliation: Kokura Memorial Hospital
name: Dr. Kenji Ando
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.