FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study

FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study - FARAPULSE Pulsed Field Ablation System Post-Market Surveillance Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055743

Enrollment

300

Registered

2024-11-01

Start date

2025-01-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients intended to be treated with FARAPULSE Pulsed Field Ablation System

Exclusion criteria

Exclusion criteria: Not Applicable

Design outcomes

Primary

Measure	Time frame
Composite Safety Endpoint (CSE) defined as one or more of the following device-or procedure-related SAEs; - Any of the following with an Onset Date within 7 days of the Index procedure: - Death - Myocardial infarction - Persistent phrenic nerve palsy - Stroke - Transient ischemic attack (TIA) - Peripheral or organ thromboembolism - Cardiac tamponade / perforation - Pericarditis - Pulmonary edema - Vascular access complications - Heart block - Gastric motility/pyloric spasm disorders Either of the following with an Onset Date at any time through the completion of 12-month follow-up visit - PVS - Atrio-esophageal fistula Treatment Success from the index procedure through the completion of 12-month follow-up visit	—

Measure

Time frame

Composite Safety Endpoint (CSE) defined as one or more of the following device-or procedure-related SAEs; - Any of the following with an Onset Date within 7 days of the Index procedure: - Death - Myocardial infarction - Persistent phrenic nerve palsy - Stroke - Transient ischemic attack (TIA) - Peripheral or organ thromboembolism - Cardiac tamponade / perforation - Pericarditis - Pulmonary edema - Vascular access complications - Heart block - Gastric motility/pyloric spasm disorders Either of the following with an Onset Date at any time through the completion of 12-month follow-up visit - PVS - Atrio-esophageal fistula Treatment Success from the index procedure through the completion of 12-month follow-up visit

—

Secondary

Measure	Time frame
Safety (AE, Device Deficiencies and mortality), demographics, device information, procedure information, medication	—

Countries

Japan

Contacts

Public ContactHiroshi Sakamoto

Boston Scientific Japan K.K. Clinical Affairs

Hiroshi.Sakamoto@bsci.com03-6853-7500

Outcome results