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To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.

NCT06358391 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-24

No results posted yet for this study

Summary

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.

Conditions

Interventions

DEVICE

TS-RF Transseptal Needle

Apply radiofrequency energy to the electrode tip via the TS-RF Generator and puncture the atrial septum

DEVICE

BRK Transseptal Needle

Cross and puncture the atrial septum with the BRK Transseptal Needle

Sponsors & Collaborators

  • Helptrial

    collaborator UNKNOWN

  • Starmed

    lead INDUSTRY

Principal Investigators

  • Sang-Weon Park, MD, Ph.D · Sejong General Hospital

  • Jong-Il Choi, MD, Ph.D · Korea University Anam Hospital

  • Jae-Sun Uhm, MD, Ph.D · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-21
Primary Completion
2025-08-21
Completion
2026-10-31

Countries

  • South Korea

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 NCT06358391 on ClinicalTrials.gov