Not Yet RecruitingNot Applicable

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

300 participantsStarted 2025-08-30

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients aged between 18 and 80 years;
✓. Confirmed diagnosis of ventricular tachycardia (VT) via electrocardiogram (ECG) or 24-hour Holter monitoring;
✓. The patient has experienced at least one episode of VT in the past 6 months and exhibits symptoms of sustained or paroxysmal ventricular tachycardia;
✓. The patient meets the criteria for ablation surgery and has clear indications for ablation;
✓. 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);
✓. Voluntarily participates and signs an informed consent form.

Exclusion criteria

✕. Uncontrolled heart failure (New York Heart Association functional class III-IV);
✕. History of acute or progressive myocardial infarction;
✕. Severe pulmonary, hepatic, or renal disease;
✕. Valvular heart disease or congenital heart disease;
✕. Excessive use of medications or medication intolerance (e.g., beta-blockers, antiarrhythmic drugs);
✕. Clinical diagnosis: Atrial tachycardia (AT)
✕. Patients aged 18 to 80 years;
✕. Diagnosed with atrial tachycardia (AT) by electrocardiogram (ECG) or Holter monitoring;

What they're measuring

primary efficacy endpoint

Timeframe: On the day of the surgery

Trial details

NCT IDNCT07079813

SponsorShanghai MicroPort EP MedTech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Ventricular Tachycardia (VT) trials