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

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.

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:

1. The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
2. subjects with ASD occluder or patch implantation;
3. hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
4. acute myocardial infarction within 4 weeks;
5. end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a heart transplant;
6. history of cerebrovascular accident within 30 days;
7. pregnant and lactating women;
8. acute systemic infection or sepsis;
9. patients who have participated in any drug and/or medical device clinical trial within 1 month before this trial;
10. atrial septal puncture within 3 months;
11. life expectancy less than one year;
12. 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