Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul

To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum.

Evaluation indicators:

Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.

Study Overview

• Status: Completed
• Conditions: Evaluation of the Radiofrequency Transseptal Puncture System; Atrial Septum Puncture
• Intervention / Treatment: Device: Radiofrequency Transseptal Puncture System and Auxiliary Device

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Heayoung Medical Technology (Suzhou) Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants scheduled to undergo transseptal access interventional cardiology procedure; The subjects were informed of the nature of the study, understood the purpose of the clinical trial, voluntarily participated and signed an informed consent form.

Exclusion Criteria:

1. The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
2. subjects with ASD occluder or patch implantation;
3. hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
4. acute myocardial infarction within 4 weeks;
5. end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a heart transplant;
6. history of cerebrovascular accident within 30 days;
7. pregnant and lactating women;
8. acute systemic infection or sepsis;
9. patients who have participated in any drug and/or medical device clinical trial within 1 month before this trial;
10. atrial septal puncture within 3 months;
11. life expectancy less than one year;
12. The investigator judged that the patient had poor compliance and could not complete the study according to the requirements; Or other circumstances in which the researcher considers the subject to be unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; RF Cross	Device: Radiofrequency Transseptal Puncture System and Auxiliary Device; The intervention in this study stands out due to its specific focus on evaluating the safety and efficacy of a radiofrequency transseptal puncture system designed exclusively for use in the atrial septum, with the purpose of establishing a passage from the right atrium to the left atrium. This system incorporates an auxiliary radiofrequency puncture device, which serves as a crucial supportive component, enhancing the overall functionality and precision of the primary transseptal puncture system. What further distinguishes this intervention from others is its utilization of radiofrequency energy to facilitate the transseptal puncture. Unlike traditional mechanical puncture methods, which can have a steep learning curve, potentially cause serious complications such as pericardial tamponade and cardiac rupture, and may be time-consuming and imprecise in predicting the puncture site, the radiofrequency puncture device provides a more controlled and predictable approach. The radiofrequenc
Active Comparator: Control Group; Braidin Cross	Device: Radiofrequency Transseptal Puncture System and Auxiliary Device; The intervention in this study stands out due to its specific focus on evaluating the safety and efficacy of a radiofrequency transseptal puncture system designed exclusively for use in the atrial septum, with the purpose of establishing a passage from the right atrium to the left atrium. This system incorporates an auxiliary radiofrequency puncture device, which serves as a crucial supportive component, enhancing the overall functionality and precision of the primary transseptal puncture system. What further distinguishes this intervention from others is its utilization of radiofrequency energy to facilitate the transseptal puncture. Unlike traditional mechanical puncture methods, which can have a steep learning curve, potentially cause serious complications such as pericardial tamponade and cardiac rupture, and may be time-consuming and imprecise in predicting the puncture site, the radiofrequency puncture device provides a more controlled and predictable approach. The radiofrequenc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of atrial septum	It is expected to last 18 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Ningbo University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: May 17, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: RF20240131; FAHNBU20240581 (Other Grant/Funding Number: Heayoung Medical Technology (Suzhou) Co., Ltd)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No