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 | Recruiting

• 1 other identifier: TS-RF system
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Arrhythmias, Cardiac; Atrial Fibrillation; Heart Diseases

Keywords

Transseptal puncture; Left atrial access; Transseptal catheterization; Radiofrequency

Outcome Measures

Primary Outcomes (1)

• First-pass TSP Success Rate (percent)

  Probability that the needle crosses from the superior vena cava to the fossa ovalis and its left atrial access is identified at a time by fluoroscopy, transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE).

  Day of procedure

Secondary Outcomes (6)

• TSP Time (Second)

  Day of procedure

• Fluoroscopy Time (Second) for TSP

  Day of procedure

• Needle cross-over between the study and control groups

  Day of procedure

• Intra-TSP procedural device-associated complications

  Day of procedure

• Changes in patient's quality of life

  before the procedure (baseline) and at 2 weeks after the procedure.

Other Outcomes (2)

• Intra-TSP procedural Adverse Events

  During procedure

• Overall Adverse Events

  for 2 weeks after the procedure

Study Arms (2)

Radiofrequency energy needle

EXPERIMENTAL

Radiofrequency energy needle(TS-RF Needle) for transseptal access

Device: TS-RF Transseptal Needle

Mechanical needle

ACTIVE COMPARATOR

Mechanical needle(BRK Transseptal Needle) for transseptal access

Device: BRK Transseptal Needle

Interventions

TS-RF Transseptal Needle DEVICE

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

Radiofrequency energy needle

BRK Transseptal Needle DEVICE

Cross and puncture the atrial septum with the BRK Transseptal Needle

Mechanical needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Diagnosed with one of the following cardiac disorders as shown in the medical record:
• \[Symptomatic arrhythmia\]
• "Atrial fibrillation" diagnostics (including paroxysmal, persistent, long-standing persistent and permanent atrial fibrillation)
• Diagnostic criteria: atrial fibrillation lasting ≥ 30 seconds as a result of standard 12-lead electrocardiogram (ECG) or single-lead ECG
• ECG feature: irregular R-R interval, lack of visible P waves, irregular atrial activation
• Symptoms: fatigue, palpitation, dyspnea, chest discomfort, sleep disorders, mental stress
• Type:
• Paroxysmal atrial fibrillation (stopping within 48 hours without any treatment; restoring the sinus rhythm with cardioversion within 7 days)
• Persistent atrial fibrillation (persisting for ≥ 7 days; including sinus rhythm restoration with direct-current cardioversion (DCC) or pharmacological cardioversion after the persistence)
• Long-standing persistent atrial fibrillation (persisting for ≥ 1 year; including cases requiring cardioversion)
• Permanent atrial fibrillation (The patient and healthcare provider accept atrial fibrillation and do not consider cardioversion; if cardioversion is considered, the atrial fibrillation is reclassified as long-standing persistent atrial fibrillation)
• "Paroxysmal Supraventricular Tachycardia" diagnostics
• = Clinical feature: The heart beats regularly 150 to 200 times per minute; the start and end of paroxysmal supraventricular tachycardia are clearly recognizable; these occur unexpectedly and stop abruptly.
• "Ectopic Atrial Rhythm Tachycardia" diagnostics

You may not qualify if:

• \[For symptomatic arrhythmia and mitral stenosis\] If any of the following applies, you cannot participate in this clinical trial.1,26,37,45,46
• Patients with significant congenital heart defects, such as atrial septal defect or pulmonary vein (PV) abnormalities (excluding patent foramen ovale (PFO)).
• Thrombus in the left atrium
• Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)
• Known or suspected left atrial myxoma.
• Unstable angina.
• Pre-existing hemidiaphragmatic paralysis
• Contraindication to anticoagulation or radiocontrast materials
• liver disease (including active hepatitis) and kidney disease.
• Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
• Malignant tumors or hematological diseases or life expectancy of less than one (1) year.
• Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
• Unwilling or unable to comply fully with study procedures and follow-up
• A pregnant woman, a woman planning on becoming pregnant, or a lactating woman.
• Ineligible for study participation in the judgment of the investigator.

Sponsors & Collaborators

• Starmed: lead
• Helptrial: collaborator

Study Sites (1)

Bucheon Sejong Hospital

Bucheon-si, South Korea

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang-Weon Park, MD, Ph.D

  Sejong General Hospital

  STUDY CHAIR

• Jong-Il Choi, MD, Ph.D

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Jae-Sun Uhm, MD, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunji shin

CONTACT

+82-31-816-3546; eunji.shin@starmed4u.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 10, 2024
• Study Start: August 21, 2024
• Primary Completion: August 21, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)