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First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient

NCT07452211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-05

No results posted yet for this study

Summary

This is the first in man study of CadioPulseTM ( pulsed field ablation system) developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can be used for Pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation. This study aims to initially verify the safety and efficacy of the device.

Conditions

  • Paroxysmal Atrial Fibrillation (PAF)

Interventions

DEVICE

CardioPulsesTM pulsed field ablation system

Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.

Sponsors & Collaborators

  • Hangzhou Dinova EP Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2022-04-10
Completion
2022-04-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452211 on ClinicalTrials.gov