Nationwide Observational Study for Persistent Atrial Fibrillation Patients with Treatment by SATAKE-HotBalloon Catheter

Nationwide Observational Study for Persistent Atrial Fibrillation Patients with Treatment by SATAKE-HotBalloon Catheter - HARVEST II Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1032230149

Enrollment

500

Registered

2023-06-17

Start date

2023-06-17

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

Drug-resistant recurrent symptomatic persistent atrial fibrillation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients over the age of 18 2. Patients scheduled for ablation with SATAKE-HotBalloon catheter for persistent atrial fibrillation

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with a life expectancy of less than 1 year due to some disease 2. Patients who requested refusal regarding the use of information in this study

Design outcomes

Primary

Measure	Time frame
12 months postoperative success rate (Including touch-up cases)	—

Secondary

Measure	Time frame
1. Acute phase success rate (including touch-up cases) Percentage of study subjects with isolated pulmonary veins (RSPV, RIPV, LSPV, LIPV) Isolated lungs for ablated pulmonary veins (RSPV, RIPV, LSPV, LIPV) Percentage of veins Success or failure of isolation: Successful if the potential is 0.1 mV or less or if the pulmonary vein potential and the left atrial potential are not synchronized. 2. 12 months postoperative safety Occurrence of all adverse events related to catheter ablation during the observation period	—

Measure

Time frame

1. Acute phase success rate (including touch-up cases) Percentage of study subjects with isolated pulmonary veins (RSPV, RIPV, LSPV, LIPV) Isolated lungs for ablated pulmonary veins (RSPV, RIPV, LSPV, LIPV) Percentage of veins Success or failure of isolation: Successful if the potential is 0.1 mV or less or if the pulmonary vein potential and the left atrial potential are not synchronized. 2. 12 months postoperative safety Occurrence of all adverse events related to catheter ablation during the observation period

—

Contacts

Public ContactFumiyuki Iida

EPS Corporation

smb-harvest2@eps.co.jp+81-3-6759-9904

Outcome results