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

NCT07079813 | Not Yet Recruiting

• 1 other identifier: XNZGQ01
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

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

  On the day of the surgery

Study Arms (1)

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

EXPERIMENTAL

Device: EasyStars™ High Density Mapping Catheter

Interventions

EasyStars™ High Density Mapping Catheter DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients presenting with clinical symptoms such as palpitations, chest tightness, or fatigue;
• Patients diagnosed with persistent or paroxysmal atrial tachycardia and meeting the criteria for ablation therapy;
• Patients who voluntarily participate and sign an informed consent form.
• Patients with severe valvular heart disease or congenital heart disease;
• Patients with severe left ventricular or right ventricular heart failure;
• Patients with severe systemic diseases, such as liver failure, kidney failure, or tumours;
• Patients with cardiomyopathy or aortic dissection;

Sponsors & Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.: lead
• Shanghai General Hospital, China: collaborator

MeSH Terms

Conditions

Tachycardia, Ventricular; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentre, prospective, single-arm, non-randomised

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 23, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-01