Clinical Research Directory

FARAPULSE™ Pulsed Field Ablation System

To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.

Feasibility Study of the FARAFLEX Mapping and PFA System

The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).

Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.

Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.

3-Dimensional Mapping System: The PULSTAR II Study

\### Study Overview * Study Name In simple terms, this study involves using a new device to treat a heart condition called "Paroxysmal Atrial Fibrillation." * Sponsor The study is sponsored by a company called Shanghai Shangyang Medical Technology Co., Ltd. * Trial Devices The study will utilize two specialized devices: 1. \*\*Nanosecond Pulsed Electric Field Ablation Device\*\*: This device emits special electrical pulses to treat the heart. 2. \*\*Magnetoelectric Dual-Positioning Petal Pulse Ablation Catheter\*\*: This is a catheter that allows for precise navigation and treatment inside the heart. * Study Purpose The purpose of this study is to verify the safety and effectiveness of this new device in treating Paroxysmal Atrial Fibrillation, with the goal of enabling its widespread use in the future. * Study Design This is a prospective, multicenter, single-arm target value study. This means: * \*\*Prospective\*\*: The study looks forward in time, tracking patient outcomes. * \*\*Multicenter\*\*: The study is conducted simultaneously across multiple hospitals. * \*\*Single-Arm Target Value\*\*: All patients receive the same treatment, which is then compared against a predetermined target value. * Sample Size The study plans to enroll 149 patients. * Primary Endpoint The main goal of the study is to determine how many patients no longer experience atrial fibrillation, atrial flutter, or atrial tachycardia symptoms within 12 months after surgery. Specifically, it measures the proportion of patients who do not have arrhythmias lasting more than 30 seconds between 3 and 12 months post-surgery, as confirmed by electrocardiograms and other monitoring methods. * Secondary Endpoints The study also includes several secondary objectives: 1. \*\*Immediate Post-Surgical Ablation Success Rate\*\*: To check how many patients have their atrial fibrillation successfully "isolated" immediately after surgery. 2. \*\*Pulse Catheter Evaluation\*\*: To assess the performance and ablation parameters of the catheter. 3. \*\*Pulse Device Evaluation\*\*: To evaluate the software operability, operational stability, and hardware connectivity of the device. * Safety Indicators The study will also monitor the safety of the treatment, including: 1. \*\*Primary Safety Endpoint\*\*: The rate of adverse events occurring within 7 days after surgery. 2. \*\*Secondary Safety Endpoint\*\*: The incidence of device-related adverse events and serious adverse events. * Inclusion Criteria Only patients who meet the following criteria can participate in the study: 1. Age between 18 and 75 years. 2. Diagnosed with Paroxysmal Atrial Fibrillation. 3. Recurrent episodes with noticeable symptoms. 4. Documented atrial fibrillation on an electrocardiogram or Holter monitor within the past year. 5. Poor response or intolerance to at least one standard antiarrhythmic medication. 6. Willingness to sign an informed consent form and comply with all study-related tests and procedures. * Exclusion Criteria Patients with the following conditions cannot participate in the study: 1. Previous atrial fibrillation surgery. 2. Presence of left atrial thrombus. 3. Inability to use effective contraception during the 12-month study period. 4. Enlarged left atrium or other cardiac issues. 5. Severe systemic infections or other health problems. 6. Recent history of other serious diseases or surgeries. 7. Bleeding tendencies or other blood disorders. 8. Participation in other clinical trials within the past 3 months.

Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.

The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging

Assessing the impact of a new atrial fibrillation (AF) catheter ablation energy on left atrial structure and function is of crucial importance. The goal of this clinical trial is to assess the effect of pulsed-field ablation of atrial fibrillation on left atrial structure.

Comparative Efficacy of 100-, 200-, & 400-mg Amiodarone in Patients With Paroxysmal AF Depending on Plasma Concentration

Amiodarone is a highly effective drug for the treatment and prevention of arrhythmias. In the 1970s and 1980s, numerous experimental and clinical studies comprehensively examined the mechanisms of amiodarone's antiarrhythmic action, as well as its effectiveness in various types of arrhythmias. This explains why drug therapy is so widespread today. According to the CAMIAT study, which included 1,202 patients with ventricular extrasystole who had suffered a myocardial infarction, amiodarone administration reduced the risk of arrhythmic death by 48.5%, and by 35% in the EMIAT study. In the GESICA study, amiodarone therapy was documented to reduce overall mortality by 45%, the incidence of sudden cardiac death by 54%, and mortality from progressive heart failure by 40%. In Russia, amiodarone is prescribed as a first-line drug for AF in 41% of cases with organic myocardial disease, in 52% as a second-line drug, and in 12.5% in the absence of organic heart damage. Moreover, the effectiveness of maintaining sinus rhythm in atrial fibrillation varies from 30 to 95.2%, which is a significant range when predicting the effectiveness of treatment. Attempts to assess amiodarone concentrations during therapy and to analyze the correlation with the achieved effects have been made repeatedly. While assessing amiodarone concentrations is generally considered inappropriate, based on the results of numerous studies, the use of monitoring is justified in certain clinical situations where the desired clinical effect or adverse events are absent. A detailed analysis of systemic reviews revealed significant shortcomings in the formation of such judgments. The groups were heterogeneous, small in number, and included, among other things, individual clinical situations and different routes of drug administration. A literature review did not reveal any data on the analysis of the concentration of amiodarone and desethylamiodarone as an anti-relapse therapy for atrial fibrillation when used consistently in doses acceptable by clinical guidelines with the possibility of titration under laboratory monitoring.

A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:

The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation

The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. In a PVI procedure, these veins are electrically isolated to prevent AF from recurring. Sometimes, the veins reconnect over time, which can lead to a return of arrhythmia. PFA is a new, non-thermal technology that uses short electrical pulses to safely and precisely treat heart tissue, reducing the risk of damage to nearby structures. The VARIPULSE system is one of these new PFA platforms. In this study, 20 adult patients with paroxysmal AF will undergo PVI using the VARIPULSE system. After 2-3 months, each patient will have a second planned procedure to check whether the pulmonary veins remain isolated. Any reconnections found will be treated immediately. The main goal is to determine how often the pulmonary veins stay durably isolated after the initial VARIPULSE treatment. Secondary goals include assessing the amount of scar tissue in the left atrium, recording any complications, and evaluating rhythm outcomes after one year. The results will help determine how effective and reliable the VARIPULSE system is for long-term treatment of AF.

SVC-isolation in Redo-AF Ablation With Isolated PV

Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed "pulmonary vein isolation"), which results in abolishment of arrhythmia recurrence in up to 85% of patients at short and mid-term follow-up. However, a subset of patients experience an atrial tachyarrhytmia recurrence and a second catheter ablation procedure has to be performed. If pulmary vein isolation is proven to be durable, other arrhythmogenic foci could be implicated in arrhythmia recurrence. Among extra-pulmonary vein foci, superior vena cava has been described as the most frequently involved in atrial fibrillation initiation. Therefore, its ablation could result in improved freedom from atrial fibrillation episodes during follow-up. In the present study, we sought to evaluate the safety and effectiveness of empirical superior vena cava isolation in terms of arrhythmia-free survival in patients with paroxysmal atrial fibrillation recurrence despite durable pulmonary vein isolation.

Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation

The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.