Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

Hangzhou NOYA MedTech

Status: Completed

Conditions: Atrial Fibrillation; Heart Diseases

Treatments: Device: AThrough radiofrequency transseptal puncture system; Device: Traditional mechanical transseptal puncture needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT06386458

AT-01

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

Radiofrequency transseptal puncture needle

Experimental group

Description:

Utilizing Radiofrequency transseptal puncture system for left atrial access

Treatment:

Device: AThrough radiofrequency transseptal puncture system

Traditional mechanical transseptal puncture needle

Active Comparator group

Description:

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Treatment:

Device: Traditional mechanical transseptal puncture needle