RecruitingNot ApplicableNCT06157437

An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia


Sponsor

Hangzhou Dinova EP Technology Co., Ltd

Enrollment

10 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new device that uses electrical pulses (called focal pulse ablation) to treat an abnormal heart rhythm called atrial flutter. Atrial flutter is when the upper chambers of the heart beat too fast in a regular, rapid pattern. The goal is to see if this new ablation system is safe and effective. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with typical atrial flutter, confirmed by an ECG or heart monitor in the last 6 months - You are willing and able to understand and participate in the study **You may NOT be eligible if...** - You have not had a confirmed episode of atrial flutter - You have conditions that make heart ablation unsafe - You are unwilling or unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFocal Pulse field Ablation

Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.


Locations(1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06157437


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