Evaluating the timing of anti-tachycardia pacing for ICD patients
A Multicenter Prospective Randomized Study to Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing
This study is testing if starting anti-tachycardia pacing sooner can help Japanese patients with implantable cardioverter defibrillators avoid unnecessary shocks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 398 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotronik SE & Co. KG Industry-sponsored |
| Locations | 1 site (Kitakyushu-city, Fukuoka) |
| Trial ID | NCT05426785 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the safety and efficacy of early multiple anti-tachycardia pacing (ATP) settings against conventional extended detection settings in Japanese patients with implantable cardioverter defibrillators (ICDs). Patients are randomized into two groups: one receiving early ATP treatment and the other receiving standard treatment. The study aims to determine the effectiveness of early ATP in preventing inappropriate shocks from the ICD. Data will be collected during hospital visits and through home monitoring over an undefined follow-up period.
Who should consider this trial
Good fit: Ideal candidates include Japanese patients who require an ICD and are either undergoing de novo implantation or have had an ICD implanted for 10 days or less.
Not a fit: Patients who have received ICD therapy or have specific conditions like Idiopathic VF may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of ventricular tachycardia and fibrillation, reducing unnecessary shocks for patients with ICDs.
How similar studies have performed: Other studies have explored ATP settings, but this specific approach focusing on early multiple ATP in a Japanese population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kitakyushu-city, Fukuoka
- Kokura Memorial Hospital — Kitakyushu-city, Fukuoka, Japan (Recruiting)
Study contacts
- Principal investigator: Dr. Kenji Ando — Kokura Memorial Hospital
- Study coordinator: Yumiko Okaniwa
- Email: yumiko.okaniwa@biotronik.com
- Phone: +81-80-3608-6761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.