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

JRCT ID: jRCT1032230149

Registered date:17/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Drug-resistant recurrent symptomatic persistent atrial fibrillation
• Date of first enrollment: 17/06/2023
• Target sample size: 500
• Study type: Observational

Outcome(s)

• Primary Outcome: 12 months postoperative success rate (Including touch-up cases)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Yamane Teiichi
• Source(s) of Monetary Support: Toray Industries, Inc.