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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai MicroPort EP MedTech Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis: Ventricular tachycardia (VT)

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • EasyStars™ High Density Mapping Catheter

    Device

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients of complex arrhythmias treated with EasyStars™ High Density Mapping CatheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

primary efficacy endpoint

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

Time frame
On the day of the surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai MicroPort EP MedTech Co., Ltd.

Lead sponsor

Shanghai General Hospital, China

Collaborator

This trial is not recruiting at the moment. You can still explore other options: