Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Heart Diseases
• Interventions: Device: Traditional mechanical transseptal puncture needle; Device: AThrough radiofrequency transseptal puncture system

• Registration Number: NCT06386458
• Lead Sponsor: Hangzhou NOYA MedTech Co. Ltm.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-11
• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional mechanical transseptal puncture needle	Traditional mechanical transseptal puncture needle	Utilizing Traditional mechanical transseptal puncture needle for left atrial access
Radiofrequency transseptal puncture needle	AThrough radiofrequency transseptal puncture system	Utilizing Radiofrequency transseptal puncture system for left atrial access

Primary Outcome Measures

Name	Time	Method
Transseptal puncture success rate.	Intraprocedural assessment	Defined as successfully completing the puncture in the atrial septum and establishing a pathway from the right atrium to the left atrium (with the sheath entering the left atrium) using the transseptal puncture system

Secondary Outcome Measures

Name	Time	Method
Initial transseptal puncture success rate.	Intraprocedural assessment	Defined as the period from the introduction of the transseptal puncture system into the femoral vein to the entry of transseptal sheath into the left atrium.
Number of attempts needed to successfully complete the transseptal puncture.	Intraprocedural assessment	During the transseptal puncture process, if the transseptal puncture system needs to be readjusted upwards and repositioned for oval fossa puncture, each readjustment should count as an additional attempt.
Time required to successfully complete the transseptal puncture.	Intraprocedural assessment	Defined as the time from when the transseptal puncture system is introduced into the femoral vein to when the transseptal sheath enters the left atrium.
Ratio of atrial septal puncture failures that cross over to the opposite group.	Intraprocedural assessment	Ratio of atrial septal puncture failures that cross over to the opposite group;

Trial Locations

Locations (4)

The 7th People's Hospital of Zhengzhou; 🇨🇳 Zhengzhou, Henan, China

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Tianjin Chest Hospital; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China