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Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

NCT06386458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

AThrough radiofrequency transseptal puncture system

Utilizing AThrough radiofrequency transseptal puncture system for left atrial access

DEVICE

Traditional mechanical transseptal puncture needle

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Sponsors & Collaborators

  • Hangzhou NOYA MedTech Co. Ltm.

    lead INDUSTRY

Principal Investigators

  • Wei Sun, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2023-05-09
Completion
2023-05-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06386458 on ClinicalTrials.gov