Atrial Tachycardia, Paroxysmal Atrial Fibrillation (PAF), Typical Atrial Flutter, Ventricular Tachycardia (VT)
Conditions
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.
Interventions
DEVICEEasyStars™ High Density Mapping Catheter
All patients underwent treatment for complex arrhythmias using EasyStars™ High Density Mapping Catheter.
Sponsors
Shanghai General Hospital, China
Shanghai MicroPort EP MedTech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentre, prospective, single-arm, non-randomised
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis: Ventricular tachycardia (VT) * 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. *
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) * Inclusion criteria: 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. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary efficacy endpoint | On the day of the surgery | The proportion of immediate success (all participating subjects) in treating rapid arrhythmias using EasyStars™ High Density Mapping Catheter in combination with cardiac ablation catheters and three-dimensional cardiac electrophysiology mapping systems |
Outcome results
None listed