InsightPFA Trial of the LotosPFA Catheter

Summary

This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.

Conditions

• Arrhythmias, Cardiac
• Paroxysmal 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.

Sponsors & Collaborators

• Insight Lifetech Co., Ltd.

  collaborator INDUSTRY

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• The Affiliated People's Hospital of Ningbo University

  collaborator OTHER_GOV

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Xiamen Cardiovascular Hospital, Xiamen University

  collaborator OTHER

• Yan'an Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Insight Medtech Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-04

Primary Completion

2025-06-09

Completion

2025-07-03

Countries

• China

Study Locations