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

NCT ID: NCT07079813

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2027-12-31

Brief Summary

The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias.

Detailed Description

The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias. In addition, the study assessed the catheter's usability and mapping performance through postoperative physician feedback.

Conditions

Ventricular Tachycardia (VT); Atrial Tachycardia; Typical Atrial Flutter; Paroxysmal Atrial Fibrillation (PAF)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients of complex arrhythmias treated with EasyStars™ High Density Mapping Catheter

Group Type: EXPERIMENTAL

EasyStars™ High Density Mapping Catheter

Intervention Type: DEVICE

All patients underwent treatment for complex arrhythmias using EasyStars™ High Density Mapping Catheter.

Interventions

EasyStars™ High Density Mapping Catheter

All patients underwent treatment for complex arrhythmias using EasyStars™ High Density Mapping Catheter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients aged between 18 and 80 years;

2. Confirmed diagnosis of ventricular tachycardia (VT) via electrocardiogram (ECG) or 24-hour Holter monitoring;

3. The patient has experienced at least one episode of VT in the past 6 months and exhibits symptoms of sustained or paroxysmal ventricular tachycardia;

4. The patient meets the criteria for ablation surgery and has clear indications for ablation;

5. The patient is in good general health and able to tolerate surgery (no severe underlying heart disease, such as severe heart failure or severe coronary artery disease);

6. Voluntarily participates and signs an informed consent form.

1. Patients aged 18 to 80 years;

2. Diagnosed with atrial tachycardia (AT) by electrocardiogram (ECG) or Holter monitoring;

3. Patients presenting with clinical symptoms such as palpitations, chest tightness, or fatigue;

4. Patients diagnosed with persistent or paroxysmal atrial tachycardia and meeting the criteria for ablation therapy;

5. Patients who voluntarily participate and sign an informed consent form.

1. Patients aged 18 to 80 years;

2. Patients diagnosed with atypical atrial flutter (AFL) via electrocardiogram (ECG) or Holter monitoring;

3. Patients with clinical symptoms (e.g., palpitations, chest tightness, fatigue, etc.) that significantly impair their quality of life;

4. Patients who meet the criteria for atrial tachycardia ablation and have no other severe comorbidities;

5. Voluntarily participate and sign an informed consent form.

1. Patients aged 18 to 80 years;

2. Diagnosed with paroxysmal atrial fibrillation (PAF) via electrocardiogram (ECG) or Holter monitoring;

3. Frequent episodes of paroxysmal atrial fibrillation with symptoms such as palpitations, fatigue, and dyspnoea, and meeting the criteria for ablation;

4. No other severe cardiac or systemic diseases, and meeting the criteria for ablation;

5. Voluntarily participating and signing the informed consent form.

1. Patients aged 18 to 80 years;

2. Diagnosed with persistent atrial fibrillation (PsAF) via electrocardiogram (ECG) or Holter monitoring;

3. Atrial fibrillation persisting for more than 7 days and symptoms affecting the patient's quality of life;

4. Clear indications for ablation and no other severe comorbidities;

5. Voluntarily participating and signing an informed consent form.

Exclusion Criteria

1. 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. Clinical diagnosis: Atrial tachycardia (AT)

1. Patients with severe valvular heart disease or congenital heart disease;

2. Patients with severe left ventricular or right ventricular heart failure;

3. Patients with severe systemic diseases, such as liver failure, kidney failure, or tumours;

4. Patients with cardiomyopathy or aortic dissection;

3. Clinical diagnosis: atypical atrial flutter (AFL)

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. Patients with a history of major cardiac surgery (e.g., heart transplantation);

4. Clinically diagnosed with paroxysmal atrial fibrillation (PAF)

1. Patients with severe valvular heart disease, aortic dissection, or cardiomyopathy;

2. High-risk patients with a history of anticoagulant therapy or currently receiving anticoagulant therapy (e.g., history of thrombosis or stroke);

3. Patients with severe underlying conditions such as cancer or severe diabetes;

5. Clinical diagnosis: Persistent atrial fibrillation (PsAF)

1. Presence of severe valvular heart disease or cardiomyopathy;

2. History of stroke or clinical evidence of thrombus formation;

3. Severe heart failure (NYHA III-IV class);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, China

OTHER

Sponsor Role: collaborator

Shanghai MicroPort EP MedTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

XNZGQ01

Identifier Type: -

Identifier Source: org_study_id