Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
+81-90-6486-6761
kazuhiro.hidaka@medtronic.com
Not Recruiting
Sept. 30, 2025
Oct. 02, 2025
1000
Observational
- Patient is >= 18 years of age
- Patient has been diagnosed with drug-resistant and recurrent symptomatic paroxysmal atrial fibrillation (pAF) or drug-resistant and symptomatic persistent AF (PsAF)
- Patient is planned catheter ablation using the commercially available PulseSelectTM PFA System
- Patient with willing and is able to comply with study requirements and give informed consent or data release (defined as legally effective, documented confirmation of a patients voluntary agreement to participate in this clinical study)
or authorization per institution and geographical requirements
- Patient is expected to be inaccessible for follow-up
- Patient is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic clinical study manager
- Patient with exclusion criteria required by local law
18age old over
No limit
Both
Treatment of the drug-resistant and recurrent symptomatic pAF or drug-resistant and symptomatic PsAF
<Efficacy>
- Estimate the rate of treatment success between 91-456 days (during 3-12 months) post-catheter ablation with the PulseSelectTM PFA system.
Treatment success is defined as freedom from documented atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) lasting at least 30 seconds in duration on a cardiac rhythm monitoring device (e.g. 12-lead ECG, Holter ECG, long-term monitoring available patched or wearable ECG and Implantable loop recorder/Implantable Cardiac Monitor), or redo ablation, and electrical or intravenous pharmacological cardioversion for AF/AFL/AT excluding a 90-day blanking period as qualifying event within 12 months after the post index ablation.
<Safety>
- Estimate serious system and/or index procedure-related adverse events for the PulseSelectTM PFA system occurring during 12-month follow-up the post index ablation
- Characterize the incidence, acute procedural success and post index ablation 12-month safety of posterior wall isolation (PWI) using the PulseSelectTM PFA System in real-world practice in Japan.
- Characterize the PulseSelectTM PFA system ablation procedure including:
- Procedure time (e.g., fluoroscopy time, left atrial (LA) dwell time, etc.)
- Lesion characteristics (number and location of PFA applications)
- Condition of systemic anesthesia or sedation, and the related medication and support devices utilized
- Change in markers of coagulation, hemolysis and kidney function
- Characterize the change of cardiac function from baseline to the 12-month follow-up visit after the post index ablation.
- Estimate change in quality of life (QoL) using the EQ-5D-5L questionnaire at baseline and at the 12-month follow-up visit.
- Estimate change in QoL using the AFEQT questionnaire at baseline and each follow-up visit.
- Characterize the standard of care and healthcare utilization for patients receiving a PulseSelectTM PFA system ablation procedure.
- Estimate the rate of treatment success from 61-456 days the post index ablation.
- Characterize the durability of the PVI in reablation.
- Characterize all system and/or procedure related adverse events.
Medtronic Japan Co., Ltd.
Medical Research Ethics Committee of Institute of Science Tokyo
