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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Atrial Fibrillation
• Intervention / Treatment: Device: AThrough radiofrequency transseptal puncture system; Device: Traditional mechanical transseptal puncture needle

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The 7th People's Hospital of Zhengzhou
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital with Nanjing Medical University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Chest Hospital
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • The First Affiliated Hospital of Ningbo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency transseptal puncture needle; Utilizing Radiofrequency transseptal puncture system for left atrial access	Device: AThrough radiofrequency transseptal puncture system; Utilizing AThrough radiofrequency transseptal puncture system for left atrial access
Active Comparator: Traditional mechanical transseptal puncture needle; Utilizing Traditional mechanical transseptal puncture needle for left atrial access	Device: Traditional mechanical transseptal puncture needle; Utilizing Traditional mechanical transseptal puncture needle for left atrial access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hangzhou NOYA MedTech Co. Ltm.
• Investigators: Principal Investigator: Wei Sun, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Atrial Fibrillation
• Other Study ID Numbers: AT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No