Comparing two devices for heart procedure access
A Prospective, Multi-center, Randomized, Single-blind, Non-inferiority Confirmatory Study Designed to Compare and Assess Efficacy and Safety Between "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 "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
This study is testing a new device for heart procedures to see if it works as well and safely as the standard needle used to access the left atrium in patients with certain heart conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Starmed Industry-sponsored |
| Locations | 1 site (Bucheon-si) |
| Trial ID | NCT06358391 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of the TS-RF system, which includes an electrosurgical generator and needle, against the conventional BRK transseptal needle used for transseptal puncture to access the left atrium. The goal is to determine if the TS-RF system is non-inferior to the BRK needle in facilitating procedures for treating symptomatic arrhythmias and mitral stenosis. The study will involve patients diagnosed with specific cardiac disorders and will assess outcomes related to the effectiveness and safety of both devices.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with symptomatic arrhythmias, particularly various forms of atrial fibrillation.
Not a fit: Patients without symptomatic arrhythmias or those under 18 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for accessing the left atrium in patients with arrhythmias and mitral stenosis.
How similar studies have performed: Previous studies have shown the efficacy of radiofrequency needles in transseptal puncture, indicating a promising approach, though this specific comparison may be novel in the local context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. ≥ 18 years of age
2. 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
= Clinical feature: Heart rhythm of less than 250 beats per minute; morphologic difference from P waves in the sinus rhythm; P waves that precede QRS waves are identifiable.
* "Ventricular Tachycardia" diagnostics = Clinical feature: Wide QRS waves appear in succession with a rapid ventricular rate of ≥ 100 beats per minute; the patients is diagnosed with persistent ventricular tachycardia if tachycardia persists for ≥ 30 seconds but with non-persistent ventricular tachycardia if not applicable.
* "Arrhythmia requiring left atrial access, including left atrial appendage occlusion, in the left atrium" diagnostics = Clinical feature: moderate or higher risk of stroke, risk of bleeding, or contraindication to anticoagulation therapy
\[Symptomatic mitral stenosis\]
-"Mitral Stenosis requiring percutaneous mitral valvuloplasty through left atrial access" diagnostics
* Diagnostic criteria: confirmation of mitral stenosis with echocardiography and assessment of severity
* Symptoms: dyspnea; shortness of breath even at rest or inability to sleep in a supine position if dyspnea worsens; may accompanied by coughing, sputum, and chest pain.
3. Understood this clinical study and voluntarily signed the informed consent form (ICF)1
Exclusion Criteria:
\[For symptomatic arrhythmia and mitral stenosis\] If any of the following applies, you cannot participate in this clinical trial.1,26,37,45,46
1. Patients with significant congenital heart defects, such as atrial septal defect or pulmonary vein (PV) abnormalities (excluding patent foramen ovale (PFO)).
2. Thrombus in the left atrium
3. Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)
4. Known or suspected left atrial myxoma.
5. Unstable angina.
6. Pre-existing hemidiaphragmatic paralysis
7. Contraindication to anticoagulation or radiocontrast materials
8. liver disease (including active hepatitis) and kidney disease.
9. Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
10. Malignant tumors or hematological diseases or life expectancy of less than one (1) year.
11. 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
12. Unwilling or unable to comply fully with study procedures and follow-up
13. A pregnant woman, a woman planning on becoming pregnant, or a lactating woman.
14. Ineligible for study participation in the judgment of the investigator.
Where this trial is running
Bucheon-si
- Bucheon Sejong Hospital — Bucheon-si, South Korea (Recruiting)
Study contacts
- Principal investigator: Jong-Il Choi, MD, Ph.D — Korea University Anam Hospital
- Study coordinator: Eunji shin
- Email: eunji.shin@starmed4u.com
- Phone: +82-31-816-3546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.