Status:
COMPLETED
Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul
Lead Sponsor:
First Affiliated Hospital of Ningbo University
Conditions:
Evaluation of the Radiofrequency Transseptal Puncture System
Atrial Septum Puncture
Eligibility:
All Genders
18-80 years
Phase:
NA
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 sep...
Eligibility Criteria
Inclusion
- 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
- The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
- subjects with ASD occluder or patch implantation;
- hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
- acute myocardial infarction within 4 weeks;
- end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a heart transplant;
- history of cerebrovascular accident within 30 days;
- pregnant and lactating women;
- acute systemic infection or sepsis;
- patients who have participated in any drug and/or medical device clinical trial within 1 month before this trial;
- atrial septal puncture within 3 months;
- life expectancy less than one year;
- 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
Key Trial Info
Start Date :
May 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06990230
Start Date
May 27 2024
End Date
September 30 2024
Last Update
May 25 2025
Active Locations (1)
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1
Heayoung Medical Technology (Suzhou) Co., Ltd
Suzhou, Jiangsu, China, 215000