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.

Hangzhou NOYA MedTech Co. Ltm.4 sites in 1 country177 target enrollmentJuly 8, 2022

ConditionsHeart Diseases Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Diseases
Sponsor: Hangzhou NOYA MedTech Co. Ltm.
Enrollment: 177
Locations: 4
Primary Endpoint: Transseptal puncture success rate.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 8, 2022

End Date

May 11, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hangzhou NOYA MedTech Co. Ltm.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient age ≥ 18 years;
•Subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route;
•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

•Echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma;
•Subjects with an atrial septal defect occluder or atrial septal patch implant;
•Hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment;
•Acute myocardial infarction occurred within the last 4 weeks;
•End-stage heart failure (ACC/AHA stage D); post-heart transplant; or awaiting heart transplant;
•Pregnant or breastfeeding women;
•Acute systemic infection or sepsis;
•Participation in any drug and/or medical device clinical trial within the last month;
•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.

Outcomes

Primary Outcomes

Transseptal puncture success rate.

Time Frame: Intraprocedural assessment

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

Secondary Outcomes

Initial transseptal puncture success rate.(Intraprocedural assessment)
Number of attempts needed to successfully complete the transseptal puncture.(Intraprocedural assessment)
Time required to successfully complete the transseptal puncture.(Intraprocedural assessment)
Ratio of atrial septal puncture failures that cross over to the opposite group.(Intraprocedural assessment)