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

NCT ID: NCT06990230

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-27
• Study Completion Date: 2024-09-30

Brief Summary

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.

Conditions

Evaluation of the Radiofrequency Transseptal Puncture System; Atrial Septum Puncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Group

RF Cross

Group Type: EXPERIMENTAL

Radiofrequency Transseptal Puncture System and Auxiliary Device

Intervention Type: 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

Control Group

Braidin Cross

Group Type: ACTIVE_COMPARATOR

Radiofrequency Transseptal Puncture System and Auxiliary Device

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role: lead

Responsible Party

Yibo Yu

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heayoung Medical Technology (Suzhou) Co., Ltd

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

FAHNBU20240581

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RF20240131

Identifier Type: -

Identifier Source: org_study_id