CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 292 enrolled
Drug / intervention
Pulsed Field Ablation (PFA) Therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06014996
NCT06014996N/ACompleted
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Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrilation:InsightPFA Trial

Insight Medtech Co., Ltd.·interventional·Posted Aug 28, 2023·Updated Aug 17, 2025

In Brief

A clinical study evaluating Pulsed Field Ablation (PFA) Therapy and Radiofrequency Ablation（RAF）Therapy for Arrhythmias, Cardiac and Paroxysmal Atrial Fibrillation. Completed, enrolled 292 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArrhythmias, Cardiac, Paroxysmal Atrial Fibrillation
CountriesChina
CollaboratorsInsight Lifetech Co., Ltd., Guangdong Provincial People's Hospital, Beijing Anzhen Hospital, Sir Run Run Shaw Hospital, Shanghai Zhongshan Hospital, The Affiliated People's Hospital of Ningbo University, The First Affiliated Hospital of Dalian Medical University, Nanfang Hospital, Southern Medical University, Xiamen Cardiovascular Hospital, Xiamen University, Yan'an Affiliated Hospital of Kunming Medical University, Weifang People's Hospital

Timeline

N/ACompletedFinished
202420252026
First PostedAug 28, 2023
Enrollment StartSep 4, 2023
Primary CompletionJun 9, 2025
Study CompletionJul 3, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 2.8 years ago

Interventions

Pulsed Field Ablation (PFA) Therapydevice

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).

Radiofrequency Ablation（RAF）Therapydevice

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.