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

First Affiliated Hospital of Ningbo University

Status: Completed

Conditions: Atrial Septum Puncture; Evaluation of the Radiofrequency Transseptal Puncture System

Treatments: Device: Radiofrequency Transseptal Puncture System and Auxiliary Device

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06990230

RF20240131

FAHNBU20240581 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Test Group

Experimental group

Description:

RF Cross

Treatment:

Device: Radiofrequency Transseptal Puncture System and Auxiliary Device

Control Group

Active Comparator group

Description:

Braidin Cross

Treatment:

Device: Radiofrequency Transseptal Puncture System and Auxiliary Device