Treatment of the drug-resistant and recurrent symptomatic pAF or drug-resistant and symptomatic PsAF
Conditions
Interventions
None listed
Sponsors
Sasano Tetsuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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. - 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Contacts
Public ContactKazuhiro Hidaka
Medtronic Japan
Outcome results
None listed