Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications

Launched by SHANGHAI MICROPORT EP MEDTECH CO., LTD. · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called the EasyStars™ High Density Mapping Catheter, which helps doctors quickly and accurately locate abnormal heart rhythms called arrhythmias. These arrhythmias include several types such as ventricular tachycardia, atrial tachycardia, atrial flutter, and different forms of atrial fibrillation. The main goal is to see if this new catheter is safe, effective, and useful during heart procedures designed to treat these rhythm problems.

People who might be eligible to participate are adults between 18 and 80 years old who have been diagnosed with one of these specific arrhythmias and who have symptoms like palpitations, chest discomfort, or fatigue that affect their daily life. Participants need to be in good enough health to undergo a heart procedure called ablation, which uses heat or cold energy to correct the abnormal rhythms. If you join the study, you will sign a consent form and receive close monitoring to ensure your safety. This study aims to improve how doctors map and treat complex heart rhythm issues, potentially leading to better outcomes for patients like you.

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Eligibility criteria

• This study included a total of 300 patients, divided into the following five categories:
• • Ventricular tachycardia (VT)
• • Atrial tachycardia (AT)
• • Atypical atrial flutter (AFL)
• • Paroxysmal atrial fibrillation (PAF)
• • Persistent atrial fibrillation (PsAF)
• For the types of cases included in this study, patients voluntarily participated and signed informed consent forms. The following are the inclusion criteria and exclusion criteria for each type of rapid arrhythmia:
• • 1. Ventricular tachycardia (VT) 1.1 Inclusion criteria: 1)Patients aged between 18 and 80 years old; 2) Diagnosed with ventricular tachycardia (VT), confirmed by electrocardiogram (ECG) or 24-hour Holter monitoring; 3)The patient has experienced at least one VT episode in the past 6 months and exhibits symptoms of persistent or paroxysmal ventricular tachycardia; 4)The patient meets the criteria for ablation and has clear indications for ablation; 5)The patient has sufficient physical condition to tolerate surgery (no severe underlying heart disease such as severe heart failure, severe coronary artery disease, etc.); 6)Voluntarily participates and signs the informed consent form. 1.2 Exclusion criteria: 1)Accompanied by uncontrolled heart failure (New York Heart Association functional class III-IV); 2)History of acute or progressive myocardial infarction; 3)Severe pulmonary, hepatic, or renal disease; 4)Valvular heart disease or congenital heart disease; 5)Excessive use of medications or medication intolerance (e.g., beta-blockers, antiarrhythmic drugs); 2.2 Atrial Tachycardia (AT) 2.1 Inclusion Criteria: 1)Patients aged 18 to 80 years; 2)Diagnosed with atrial tachycardia (AT), confirmed by electrocardiogram (ECG) or Holter monitoring; 3)Presents with clinical symptoms such as palpitations, chest tightness, or fatigue; 4)Confirmed to have persistent or paroxysmal atrial tachycardia with indications for ablation therapy; 5)Voluntarily participates and signs an informed consent form. 2.2 Exclusion criteria: 1)Patients with severe valvular heart disease or congenital heart disease; 2)Concurrent severe left ventricular or right ventricular heart failure; 3)Presence of severe systemic diseases such as liver or kidney failure, or tumours; 4)Patients with cardiomyopathy or aortic dissection; 3.3 Atypical atrial flutter (AFL) 3.1 Inclusion Criteria: 1)Patients aged between 18 and 80 years; 2)Diagnosed with atypical atrial flutter (AFL), confirmed by electrocardiogram (ECG) or Holter monitoring; 3)Presence of clinical symptoms (e.g., palpitations, chest tightness, fatigue, etc.), which significantly impact the patient's quality of life; 4)Patients with indications for atrial flutter ablation and no other severe comorbidities; 5)Voluntary participation and signed informed consent. 3.2 Exclusion criteria: 1)Patients with severe heart disease, such as cardiomyopathy or severe valvular disease; 2)Patients with severe pulmonary disease, such as pulmonary arterial hypertension; 3)History of major cardiac surgery (e.g., heart transplantation); 4 Paroxysmal Atrial Fibrillation (PAF) 4.1 Inclusion Criteria: 1)Patients aged between 18 and 80 years; 2)Diagnosed with paroxysmal atrial fibrillation (PAF), confirmed by electrocardiogram (ECG) or Holter monitoring; 3)Frequent episodes of paroxysmal atrial fibrillation, with symptoms such as palpitations, fatigue, and shortness of breath, and meeting the criteria for ablation; 4)No other significant cardiac or systemic diseases, and clear indications for ablation; 5)Voluntarily participating and signing the informed consent form. 4.2 Exclusion Criteria: 1)Patients with severe valvular heart disease, aortic dissection, or cardiomyopathy; 2)High-risk patients with a history of or currently receiving anticoagulant therapy (e.g., thrombosis, stroke history); 3)Patients with severe underlying conditions such as cancer or severe diabetes; 5 Persistent atrial fibrillation (PsAF) 5.1 Inclusion Criteria: 1)Patients aged between 18 and 80 years; 2)Diagnosed with persistent atrial fibrillation (PsAF), confirmed by electrocardiogram (ECG) or Holter monitoring; 3)Atrial fibrillation persists for more than 7 days and symptoms impair the patient's quality of life; 4)Have clear indications for ablation and no other severe comorbidities; 5)Voluntarily participates and signs an informed consent form. 5.2 Exclusion Criteria: 1)Presence of severe valvular heart disease or cardiomyopathy; 2)History of stroke or clinical evidence of thrombus formation; 3)Severe heart failure (NYHA class III-IV); 4) High-risk cardiac conditions (e.g., acute myocardial infarction, coronary artery disease); In the above different types of rapid arrhythmias, the inclusion criteria primarily focus on the diagnosis and clinical symptom control of different arrhythmia types, while the exclusion criteria focus on avoiding patients with severe comorbidities or those unable to tolerate surgery. Through this patient screening method, the safety of the study and the accuracy of the data are ensured, thereby enabling a better assessment of the clinical efficacy of the new EasyStars catheter.