Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

Atrial Fibrillation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06386458
• Other study ID #: AT-01
• Status: Completed
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: April 2024
• Source: Hangzhou NOYA MedTech Co. Ltm.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: May 11, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases

Intervention

Device:
• AThrough radiofrequency transseptal puncture system
Utilizing AThrough radiofrequency transseptal puncture system for left atrial access
• Traditional mechanical transseptal puncture needle
Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	The 7th People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou NOYA MedTech Co. Ltm.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transseptal puncture success rate.	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	Intraprocedural assessment
Secondary	Initial transseptal puncture success rate.	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.	Intraprocedural assessment
Secondary	Time required to successfully complete the transseptal puncture.	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.	Intraprocedural assessment
Secondary	Number of attempts needed to successfully complete the transseptal puncture.	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.	Intraprocedural assessment
Secondary	Ratio of atrial septal puncture failures that cross over to the opposite group.	Ratio of atrial septal puncture failures that cross over to the opposite group;	Intraprocedural assessment