Clinical trial NCT06358391: To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Keywords: Transseptal puncture
Left atrial access
Transseptal catheterization
Radiofrequency
Lead sponsor: Starmed
Sponsor class: INDUSTRY
Collaborators: name: Helptrial
First posted: 2024-04-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The efficacy and safety of radiofrequency (RF) needles in transseptal puncture have been well established through several comparative clinical studies. In foreign countries, RF needles have already been used for transseptal puncture for more than 20 years since the FDA approval of the first RF Needle. However, in Korea, despite the fact that it has been approximately 30 years since the initiation of radiofrequency catheter ablation (RFCA) for the treatment of arrhythmia, only the conventional mechanical needles have still been available after authorization for transseptal puncture that is the key for the treatment of cardiac disorders such as mitral stenosis as well as a part of RFCA for the treatment of arrhythmia.

Therefore, this study aims 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.

Eligibility 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.

Primary outcomes:
measure: First-pass TSP Success Rate (percent)
timeFrame: Day of procedure
Secondary outcomes:
measure: TSP Time (Second)
timeFrame: Day of procedure
measure: Fluoroscopy Time (Second) for TSP
timeFrame: Day of procedure
measure: Needle cross-over between the study and control groups
timeFrame: Day of procedure
measure: Intra-TSP procedural device-associated complications
timeFrame: Day of procedure
measure: Changes in patient's quality of life
timeFrame: before the procedure (baseline) and at 2 weeks after the procedure.
measure: Complications
timeFrame: for 2 weeks after the procedure
Other outcomes:
measure: Intra-TSP procedural Adverse Events
timeFrame: During procedure
measure: Overall Adverse Events
timeFrame: for 2 weeks after the procedure
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
Study officials:
affiliation: Sejong General Hospital
name: Sang-Weon Park, MD, Ph.D
role: STUDY_CHAIR
affiliation: Korea University Anam Hospital
name: Jong-Il Choi, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Jae-Sun Uhm, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: