Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Helptrial | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency energy needle | Experimental | Radiofrequency energy needle(TS-RF Needle) for transseptal access |
|
| Mechanical needle | Active Comparator | Mechanical needle(BRK Transseptal Needle) for transseptal access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-RF Transseptal Needle | Device | Apply radiofrequency energy to the electrode tip via the TS-RF Generator and puncture the atrial septum |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TSP Time (Second) | Time from the point where the needle crosses from the superior vena cava to the fossa ovalis to the point where its left atrial access is identified by fluoroscopy, transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE). | Day of procedure |
| Fluoroscopy Time (Second) for TSP |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-TSP procedural Adverse Events | Types and numbers of adverse events, including all complications that occurred during TSP, such as perforations, damages and bleedings in tissues other than the atrial septum due to needles, sheaths, dilators, and other catheters, replacement with the same needle product, and deterioration of patient's vital signs. | During procedure |
Inclusion Criteria:
≥ 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 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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eunji shin | Contact | +82-31-816-3546 | 603 | eunji.shin@starmed4u.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon Sejong Hospital | Recruiting | Bucheon-si | South Korea |
There is not a plan to make IPD available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BRK Transseptal Needle | Device | Cross and puncture the atrial septum with the BRK Transseptal Needle |
|
Time from the point where invasive vascular monitoring is initiated with fluoroscopy following the femoral venous puncture and then the needle inserted into the femoral vein is visible on the fluoroscope's fluorescent screen to the point where the needle tip's left atrial access after TSP is identified. |
| Day of procedure |
| Needle cross-over between the study and control groups | Perform TSP by switching the needle from the BRK needle in the control group to the TS-RF needle in the study group, or from the TS-RF needle in the study group to the BRK needle in the control group. Collect the data based on the recorded videos and procedure record sheets. (Number of subjects who switched needles and percentage in each group) | Day of procedure |
| Intra-TSP procedural device-associated complications | Collect and total the numbers of intra-TSP procedural device-associated complications for each group based on the procedure record sheets and then calculate and compare the group-specific incidence rates (percent). | Day of procedure |
| Changes in patient's quality of life | Check the improvement in patient's quality of life by measuring the degree of discomfort due to symptomatic arrhythmia or mitral stenosis before the procedure (baseline) and at 2 weeks after the procedure. Calculate and compare group-specific mean changes in EQ-5D-5L and EQ-VAS before the procedure (baseline) and at the follow-up visit 2 weeks after the procedure. It consists of 5 multiple-choice questions asking about current health status and 1 question (visual analogue scale, VAS) that displays subjective health level (0 to 100 points) in the form of a thermometer. | before the procedure (baseline) and at 2 weeks after the procedure. |
| Complications | Check the complications collected during the hospitalization period within 7 days immediately after the procedure and at the follow-up visit 2 weeks after the procedure, including the following two durations:.
| for 2 weeks after the procedure |
| Overall Adverse Events | Types and numbers of all adverse events including all complications occurring from the time of subject enrollment to the end of follow-up visit at 2 weeks after TSP, including the following three durations:
| for 2 weeks after the procedure |
| Severance Hospital |
| Principal Investigator |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided