InsightPFA Trial of the LotosPFA Catheter

NACompletedINTERVENTIONAL
Enrollment

292

Participants

Timeline

Start Date

September 4, 2023

Primary Completion Date

June 9, 2025

Study Completion Date

July 3, 2025

Conditions
Arrhythmias, CardiacParoxysmal Atrial Fibrillation
Interventions
DEVICE

Pulsed Field Ablation (PFA) Therapy

In the test group, subjects will undertake PVI using the PFA system including a nanosecond-scale pulsed field generator (InRythm, Insight Lifetech, Shenzhen, China), a lotos catheter that is expandable over the wire (LotosPFA, Insight Lifetech), and a customized 12-French steerable sheath (InBridge, Insight Lifetech).

DEVICE

Radiofrequency Ablation(RAF)Therapy

In the control group, subjects will undergo PVI using an RFA system including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter (Biosense Webster Inc., Diamond Bar, CA, USA). PVI was performed with AI values of 400-450 in the anterior, 300-350 at the posterior wall of the LA.

Trial Locations (10)

Unknown

Beijing Anzhen Hospital, Beijing

Xiamen Cardiovascular Hospital, Xiamen University, Xiamen

Guangdong Provincial People's Hospital, Guangzhou

Nanfang Hospital, Southern Medical University, Guangzhou

The First Affiliated Hospital of Dalian Medical University, Dalian

Weifang People's Hospital, Weifang

Shanghai Zhongshan Hospital, Shanghai

Yan'an Affiliated Hospital of Kunming Medical University, Kunming

Sir Run Run Shaw Hospital, Hanzhou

The Affiliated People's Hospital of Ningbo University, Ningbo

All Listed Sponsors
collaborator

Insight Lifetech Co., Ltd.

INDUSTRY

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

Beijing Anzhen Hospital

OTHER

collaborator

Sir Run Run Shaw Hospital

OTHER

collaborator

Shanghai Zhongshan Hospital

OTHER

collaborator

The Affiliated People's Hospital of Ningbo University

OTHER_GOV

collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

collaborator

Nanfang Hospital, Southern Medical University

OTHER

collaborator

Xiamen Cardiovascular Hospital, Xiamen University

OTHER

collaborator

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

collaborator

Weifang People's Hospital

OTHER

lead

Insight Medtech Co., Ltd.

INDUSTRY

NCT06014996 - InsightPFA Trial of the LotosPFA Catheter | Biotech Hunter | Biotech Hunter