Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul

To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum.

Evaluation indicators:

Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.

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Key information

Conditions

Evaluation of the Radiofrequency Transseptal Puncture System Atrial Septum Puncture

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heayoung Medical Technology (Suzhou) Co., Ltd

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants scheduled to undergo transseptal access interventional cardiology procedure; The subjects were informed of the nature of the study, understood the purpose of the clinical trial, voluntarily participated and signed an informed consent form.

Exclusion criteria

The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
subjects with ASD occluder or patch implantation;
hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
acute myocardial infarction within 4 weeks;
end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a heart transplant;
history of cerebrovascular accident within 30 days;
pregnant and lactating women;
acute systemic infection or sepsis;
patients who have participated in any drug and/or medical device clinical trial within 1 month before this trial;
atrial septal puncture within 3 months;
life expectancy less than one year;
The investigator judged that the patient had poor compliance and could not complete the study according to the requirements; Or other circumstances in which the researcher considers the subject to be unsuitable for the study

Treatment and study plan

Radiofrequency Transseptal Puncture System and Auxiliary Device

Device

The intervention in this study stands out due to its specific focus on evaluating the safety and efficacy of a radiofrequency transseptal puncture system designed exclusively for use in the atrial septum, with the purpose of establishing a passage from the right atrium to the left atrium. This system incorporates an auxiliary radiofrequency puncture device, which serves as a crucial supportive component, enhancing the overall functionality and precision of the primary transseptal puncture system.

What further distinguishes this intervention from others is its utilization of radiofrequency energy to facilitate the transseptal puncture. Unlike traditional mechanical puncture methods, which can have a steep learning curve, potentially cause serious complications such as pericardial tamponade and cardiac rupture, and may be time-consuming and imprecise in predicting the puncture site, the radiofrequency puncture device provides a more controlled and predictable approach. The radiofrequenc

Primary outcomes

Success rate of atrial septum

Time frame: It is expected to last 18 months

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: May 25, 2025
Registry last updated: May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.