Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Study Evaluating the Safety and Efficacy of the AThrough Radiofrequency Transseptal Puncture System in Atrial Septal Puncture.

This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups.

Inclusion Criteria:

1. Patient age ≥ 18 years;
2. Subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route;
3. Subjects have been informed about the nature of the study, understand the purpose of the clinical trial, and voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. Echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma;
2. Subjects with an atrial septal defect occluder or atrial septal patch implant;
3. Hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment;
4. Acute myocardial infarction occurred within the last 4 weeks;
5. End-stage heart failure (ACC/AHA stage D); post-heart transplant; or awaiting heart transplant;
6. Pregnant or breastfeeding women;
7. Acute systemic infection or sepsis;
8. Participation in any drug and/or medical device clinical trial within the last month;
9. Researchers judge the patient's compliance to be poor, unable to complete the study as required; or other situations deemed by the researchers as making the subject unsuitable for participation in the study.